[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-PYP":3},{"classification":4,"mappedDevices":30,"similarCandidates":31,"relatedClassifications":111,"syncDates":159},{"id":5,"product_code":6,"device_name":7,"device_class":8,"regulation_number":9,"medical_specialty":10,"medical_specialty_description":11,"review_panel":10,"submission_type_id":8,"definition":12,"implant_flag":13,"life_sustain_support_flag":13,"gmp_exempt_flag":13,"raw":14,"created_at":25,"updated_at":26,"recall_count":27,"latest_recall_date":28,"k510_count":29,"pma_count":27,"event_count":27},615,"PYP","Low-Density Lipoprotein (Ldl) Cholesterol Sub-Fraction Test","1","862.1475","CH","Clinical Chemistry","For the quantitative determination of low-density lipoprotein (LDL) cholesterol sub-fractions.",false,{"openfda":15,"definition":12,"device_name":7,"review_code":21,"device_class":8,"implant_flag":22,"product_code":6,"review_panel":10,"gmp_exempt_flag":22,"third_party_flag":23,"medical_specialty":10,"regulation_number":9,"submission_type_id":8,"unclassified_reason":21,"life_sustain_support_flag":22,"medical_specialty_description":11,"summary_malfunction_reporting":24},{"k_number":16,"fei_number":18,"registration_number":20},[17],"K161679",[19],"3003871639",[19],"","N","Y","Ineligible","2026-08-18T05:52:48.222586+00:00","2026-08-18T22:05:38.961415+00:00",0,null,1,[],[32,41,49,58,66,73,81,88,96,103],{"medical_device_id":33,"generic_name":34,"class_classification":35,"jmdn_code":36,"name_similarity":37,"definition_similarity":38,"vector_similarity":39,"score":40},3521,"コレステロール分析装置","Ⅰ","30855000",0.1875,0.168067,0.713391,0.0327869,{"medical_device_id":42,"generic_name":43,"class_classification":35,"jmdn_code":44,"name_similarity":45,"definition_similarity":46,"vector_similarity":47,"score":48},3502,"蛋白分画電気泳動分析装置","31365000",0.176471,0.147059,0.637781,0.0322581,{"medical_device_id":50,"generic_name":51,"class_classification":52,"jmdn_code":53,"name_similarity":54,"definition_similarity":55,"vector_similarity":56,"score":57},1592,"肺機能検査用フィルタ","Ⅱ","70086000",0.128205,0.122449,0.603511,0.0242504,{"medical_device_id":59,"generic_name":60,"class_classification":52,"jmdn_code":61,"name_similarity":62,"definition_similarity":63,"vector_similarity":64,"score":65},1639,"脂肪・除脂肪量分析装置","36022010",0.028169,0.0592105,0.634856,0.015873,{"medical_device_id":67,"generic_name":68,"class_classification":52,"jmdn_code":69,"name_similarity":70,"definition_similarity":71,"vector_similarity":72,"score":65},2071,"歯科用吸引管","70317000",0.153846,0.119403,0.447937,{"medical_device_id":74,"generic_name":75,"class_classification":52,"jmdn_code":76,"name_similarity":77,"definition_similarity":78,"vector_similarity":79,"score":80},1601,"神経疾患診断用定量的感覚検査器","37349000",0.0980392,0.114379,0.632285,0.015625,{"medical_device_id":82,"generic_name":83,"class_classification":52,"jmdn_code":84,"name_similarity":85,"definition_similarity":86,"vector_similarity":87,"score":80},2306,"脂肪吸引用カテーテル","36107000",0.151515,0.127451,0.528061,{"medical_device_id":89,"generic_name":90,"class_classification":52,"jmdn_code":91,"name_similarity":92,"definition_similarity":93,"vector_similarity":94,"score":95},2777,"歯科接着・充填材料用表面硬化保護材","70858000",0.141414,0.172043,0.432272,0.0153846,{"medical_device_id":97,"generic_name":98,"class_classification":35,"jmdn_code":99,"name_similarity":100,"definition_similarity":101,"vector_similarity":102,"score":95},3503,"デンシトメトリー分析装置","15129000",0.084507,0.120879,0.630684,{"medical_device_id":104,"generic_name":105,"class_classification":35,"jmdn_code":106,"name_similarity":107,"definition_similarity":108,"vector_similarity":109,"score":110},3523,"グリコヘモグロビン分析装置","35968000",0.0126582,0.0841584,0.629823,0.0151515,[112,116,120,124,128,132,136,140,144,147,150,153,156],{"product_code":113,"device_name":114,"device_class":8,"k510_count":115},"LBS","Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl",80,{"product_code":117,"device_name":118,"device_class":8,"k510_count":119},"LBR","Ldl & Vldl Precipitation, Hdl",66,{"product_code":121,"device_name":122,"device_class":8,"k510_count":123},"MSJ","Apolipoproteins",50,{"product_code":125,"device_name":126,"device_class":8,"k510_count":127},"MRR","System, Test, Low Density, Lipoprotein",31,{"product_code":129,"device_name":130,"device_class":8,"k510_count":131},"JHO","Electrophoretic Separation, Lipoproteins",26,{"product_code":133,"device_name":134,"device_class":8,"k510_count":135},"JHM","Colorimetric Method, Lipoproteins",9,{"product_code":137,"device_name":138,"device_class":8,"k510_count":139},"LBT","Electrophoresis, Cholesterol Via Esterase-Oxidase, Hdl",8,{"product_code":141,"device_name":142,"device_class":8,"k510_count":143},"JHN","Turbidimetric Method, Lipoproteins",7,{"product_code":145,"device_name":146,"device_class":8,"k510_count":29},"JHL","Microdensitometry Method, Lipoproteins",{"product_code":148,"device_name":149,"device_class":8,"k510_count":29},"JHQ","Nephelometric Method, Lipoproteins",{"product_code":151,"device_name":152,"device_class":8,"k510_count":27},"JHP","Radial Immunodiffusion, Lipoproteins",{"product_code":154,"device_name":155,"device_class":8,"k510_count":27},"JQI","Rotating Disc, Plasma Viscometry",{"product_code":157,"device_name":158,"device_class":8,"k510_count":27},"MSM","System, Test, Lipoprotein(A)",{"510k":160,"classification":161,"enforcement":162,"event":163,"pma":164,"warning_letter":165},"2026-08-18T06:35:18.347+00:00","2026-08-18T05:52:53.75+00:00","2026-08-18T08:01:54.918+00:00","2026-08-19T02:58:35.995+00:00","2026-08-18T06:36:30.549+00:00","2026-08-18T06:42:29.411+00:00"]