FDA Product Code
FDA Product Code CHH — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1175
510(k) Clearances — 230 records · page 1 of 3
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K251091 | Lipids | Truvian Health | 2025-12-30 | Traditional | PDF ↗ |
| K232404 | CHOLESTEROL; HDL-cholesterol ; LDL-cholesterol; TRIGLYCERIDES | Medicon Hellas S.A | 2024-08-09 | Traditional | PDF ↗ |
| K203597 | Cholesterol2 | Abbott Ireland Diagnostics Division | 2022-06-30 | Traditional | PDF ↗ |
| K190490 | VITROS XT Chemistry Products TRIG-CHOL Slides | Ortho-Clinical Diagnostics, Inc. | 2019-03-27 | Traditional | PDF ↗ |
| K181373 | Extended Lipid Panel Assay | Laboratory Corporation of America Holdings | 2018-10-18 | Traditional | PDF ↗ |
| K180504 | Mission Lipid Panel Monitoring System | ACON Laboratories, Inc. | 2018-03-28 | Special | PDF ↗ |
| K163406 | Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring System | ACON Laboratories, Inc. | 2017-07-11 | Traditional | PDF ↗ |
| K151545 | CardioChek Plus Test System, CardioChek Home Test System, CardioChek PA Test System, CardioChek PA Home Test System | Polymer Technology Systems, Inc. | 2016-12-22 | Traditional | PDF ↗ |
| K150654 | Cholesterol | Randox Laboratories, Ltd. | 2015-09-29 | Traditional | PDF ↗ |
| K132031 | AFINION LIPID PANEL AND AFINION LIPID PANEL CONTROL | Axis-Shield Poc AS | 2014-03-21 | Traditional | PDF ↗ |
| K130200 | PICCOLO TOTAL CHOLESTEROL - CAPILLARY TEST SYSTEM | Abaxis, Inc. | 2013-02-15 | Traditional | PDF ↗ |
| K122757 | ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT, ACE TRIGLYCERIDES REAGENT | Alfa Wassermann Diagnostic Technologies, Inc. | 2012-10-05 | Traditional | PDF ↗ |
| K120202 | EON CHOLESTEROL REAGENT | Vital Diagnostics Pty., Ltd. | 2012-07-27 | Traditional | PDF ↗ |
| K113262 | ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT-C, ACE-TRISLYCERIDES REAGENT | Alfa Wassermann Diagnostic Technologies, Inc. | 2012-07-03 | Traditional | PDF ↗ |
| K112538 | ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT, ACE TRIGLYCERIDES REAGENT | Alfa Wassermann Diagnostic Technologies, Inc. | 2012-03-29 | Traditional | PDF ↗ |
| K111753 | HITACHI CLINICAL ANALYZER S TEST REAGENT CATRIDGE FOR: CHOLESTROL, HDL, LDL, AND TRIGLYCERIDE | Hitachi Chemical Diagnostics, Inc. | 2011-12-14 | Traditional | PDF ↗ |
| K091413 | S-TEST CHOLESTEROL (CHO), MODEL RC0009, S-TEST HDL CHOLESTEROL (HDL), MODEL RC0015, S-TEST TRIGLYCERIDES (TG) | Alfa Wassermann, Inc. | 2009-10-26 | Traditional | PDF ↗ |
| K080623 | CHOLESTEROL OXIDASE JASE, AND GLYCEROL INASE TRIGLYCERIDES, MODEL NA | Jas Diagnostics, Inc. | 2008-11-17 | Traditional | PDF ↗ |
| K072249 | EASYRA CHOLESTEROL REAGENT; EASYRA CALCIUM REAGENT REAGENT | Medica Corp. | 2008-02-20 | Traditional | PDF ↗ |
| K071593 | PTS PANELS CHOL+HDL PANEL TEST STRIPS | Polymer Technology Systems, Inc. | 2007-10-15 | Special | PDF ↗ |
| K062026 | VAP-NT CHOLESTEROL TEST | Atherotech, Inc. | 2007-03-06 | Traditional | PDF ↗ |
| K051376 | ACCUCHEK INSTANT PLUS DUAL TESTING SYSTEM, ACCUCHEK INSTANT PLUS CHOLESTEROL, ACCUCHEK INSTANT PLUS GLUCOCOSE | Roche Diagnostics | 2005-08-23 | Traditional | PDF ↗ |
| K042443 | SPOTCHEM HDL, TOTAL CHOLESTEROL AND TRIGLYCERIDE REAGENT TESTS AND PANEL | Arkray, Inc. | 2004-11-24 | Traditional | PDF ↗ |
| K031824 | COBAS INTEGRA CHOLESTEROL GEN. 2 | Roche Diagnostics Corp. | 2003-07-09 | Special | PDF ↗ |
| K023642 | PICCOLO TOTAL CHOLESTEROL TEST SYSTEM | Abaxis, Inc. | 2003-01-24 | Traditional | PDF ↗ |
| K023558 | PTS PANELS LIPID PANEL TEST STRIPS | Polymer Technology Systems, Inc. | 2002-11-15 | Special | PDF ↗ |
| K022898 | PTS PANELS LIPID PANEL TEST STRIPS | Polymer Technology Systems, Inc. | 2002-09-24 | Special | PDF ↗ |
| K013173 | BIOSCANNER PLUS; LIPID PANEL TEST STRIPS | Polymer Technology Systems, Inc. | 2001-10-22 | Special | PDF ↗ |
| K011970 | BIOSAFE CHOLESTEROL PROFILE BLOOD COLLECTION AND TRANSPORT SYSTEM | Biosafe Laboratories, Inc. | 2001-09-26 | Traditional | PDF ↗ |
| K001032 | RLP-CHOLESTEROL IMMUNOSEPARATION ASSAY | Otsuka Pharmaceutical Co., Ltd. | 2000-07-24 | Traditional | PDF ↗ |
| K000610 | RESOLUTION CHOLESTEROL MONITOR | Lifestream Technologies, Inc. | 2000-07-21 | Traditional | PDF ↗ |
| K000900 | ATAC PAK CHOLESTEROL REAGENT AND ATAC CALLIBRATOR KITS | Elan Holdings, Inc. | 2000-05-02 | Traditional | PDF ↗ |
| K993096 | PRIVALINK SOFTWARE ACCESSORY TO THE LIFESTREAM CHOLESTEROL MONITOR | Lifestream Technologies, Inc. | 1999-12-20 | Traditional | PDF ↗ |
| K992803 | SIGMA DIAGNOSTICS INFINITY CHOLESTEROL REAGENT, MODELS 401-25, 401-100P, 401-500P, 401-2000P, 402-20, 02-1OOP | Sigma Diagnostics, Inc. | 1999-09-13 | Traditional | PDF ↗ |
| K991083 | RLP CHOLESTEROL IMMUNOSEPARATION ASSAY | Otsuka Pharmaceutical Co., Ltd. | 1999-08-20 | Traditional | PDF ↗ |
| K992132 | CHOLESITE TEST SYSTEM | Gds Technology, LLC | 1999-08-20 | Traditional | PDF ↗ |
| K990688 | MTM BIOSCANNER C TEST STRIPS | Polymer Technology Systems, Inc. | 1999-06-24 | Traditional | PDF ↗ |
| K981345 | CHOLESTRON PRO II CHOLESTEROL TEST | Lifestream Diagnostics, Inc. | 1998-10-01 | Traditional | PDF ↗ |
| K982469 | HICHEM CHOLESTEROL REAGENT KIT | Elan Pharma, Inc. | 1998-08-19 | Traditional | PDF ↗ |
| K981181 | ENA-C-T TOTAL CHOLESTEROL TEST MODEL F 20000, (PHYSICIAN DIRECTED USE) | Actimed Laboratories, Inc. | 1998-08-03 | Traditional | PDF ↗ |
| K982118 | CARESIDE ANALYZER | Exigent Diagnostics, Inc. | 1998-07-24 | Traditional | PDF ↗ |
| K981493 | MTM BIOSCANNER C TEST STRIPS MODEL NUMBER BSA 200, BSA 210, BSA 220 | Polymer Technology Systems, Inc. | 1998-07-22 | Traditional | PDF ↗ |
| K981652 | CHOL | Abbott Laboratories | 1998-06-29 | Traditional | PDF ↗ |
| K981476 | CHOL | Abbott Laboratories | 1998-06-25 | Traditional | PDF ↗ |
| K980667 | INFINITY CHOLESTEROL REAGENT (PROCEDURE NO. 401) | Sigma Diagnostics, Inc. | 1998-04-21 | Traditional | PDF ↗ |
| K973284 | COBAS INTEGRA HDL-CHOLESTEROL DIRECT | Roche Diagnostic Systems, Inc. | 1997-12-18 | Traditional | PDF ↗ |
| K972853 | CHOLESTEROL RAPID LIQUID REAGENT | Reagents Applications, Inc. | 1997-09-24 | Traditional | PDF ↗ |
| K971072 | CHOLESTEROL REAGENT | Derma Media Lab., Inc. | 1997-06-20 | Traditional | PDF ↗ |
| K971505 | SYNCHRON SYSTEMS CHOLESTEROL (CHOL) REAGENT | Beckman Instruments, Inc. | 1997-06-11 | Traditional | PDF ↗ |
| K964660 | PARAMAX CHOLESTEROL REAGENT | Dade Intl., Inc. | 1997-06-04 | Traditional | PDF ↗ |
| K971345 | CHOL OR CHOLESTEROL | Carolina Liquid Chemistries Corp. | 1997-05-29 | Traditional | PDF ↗ |
| K962890 | CHOLESTEROL-INCORPORATING DYNAMIC STAB TECH (DST) | Trace Scientific , Ltd. | 1996-09-27 | Traditional | PDF ↗ |
| K960377 | ENA-C-T TOTAL CHOLESTEROL TEST | Actimed Laboratories, Inc. | 1996-05-02 | Traditional | PDF ↗ |
| K944458 | ACCU-CHEK INSTANT PLUS CHOLOESTEROL TEST | Boehringer Mannheim Corp. | 1996-03-06 | Traditional | PDF ↗ |
| K946161 | DMA TOTAL CHOLESTEROL PROCEDURE | Data Medical Associates, Inc. | 1995-08-23 | Traditional | PDF ↗ |
| K952127 | BOEHRINGER MANNHEIM CHOLESTEROL ASSAY | Boehringer Mannheim Corp. | 1995-07-20 | Traditional | PDF ↗ |
| K950164 | PICCOLO(TM) PRIMARY HEALTH PANEL REAGENT ROTOR | Abaxis, Inc. | 1995-04-13 | Traditional | PDF ↗ |
| K943599 | CHEM TRAK ACCUMETER | Chemtrak, Inc. | 1995-03-21 | Traditional | PDF ↗ |
| K946066 | TOTAL CHOLESTEROL, HDL CHOLESTEROL AND GLUCOSE PANEL | Cholestech Corp. | 1995-02-22 | Traditional | PDF ↗ |
| K946065 | TOTAL CHOLESTEROLM HDL CHOLESTEROL AND TRIGLYCERIDES PANEL | Cholestech Corp. | 1995-02-22 | Traditional | PDF ↗ |
| K946064 | TOTAL CHOLESTEROL CASSETTE | Cholestech Corp. | 1995-02-22 | Traditional | PDF ↗ |
| K946063 | TOTAL CHOLESTEROL AND HDL CHOLESTEROL PANEL | Cholestech Corp. | 1995-02-22 | Traditional | PDF ↗ |
| K946067 | TOTAL CHOLESTEROL, HDL CHOLESTEROL, TRIGLYCERIDES AND GLUCOSE PANEL | Cholestech Corp. | 1995-02-22 | Traditional | PDF ↗ |
| K943027 | CHOLESTEROL QVET | Prisma Systems | 1995-01-27 | Traditional | PDF ↗ |
| K941573 | ROCHE REAGENT | Roche Diagnostic Systems, Inc. | 1994-10-31 | Traditional | PDF ↗ |
| K923504 | CHOLESTEROL ENZYMATIC ENDPOINT | Randox Laboratories, Ltd. | 1994-01-10 | Traditional | PDF ↗ |
| K935136 | CHOLESTEROL (CHOL) TEST ITEM NO. 65410 | Em Diagnostic Systems, Inc. | 1993-12-16 | Traditional | PDF ↗ |
| K934046 | BECKMAN CHOLESTEROL REAGENT | Beckman-Diagnostic Systems Group | 1993-10-28 | Traditional | PDF ↗ |
| K914432 | ACCUMETER(R) CHOLESTEROL SELF-TEST | Chemtrak, Inc. | 1993-03-02 | Traditional | PDF ↗ |
| K925603 | OLYMPUS CHOLESTEROL REAGENT | Olympus Corp. | 1993-02-08 | Traditional | PDF ↗ |
| K924508 | CHOLESTEROL TEST ITEM# 42374/93, 42322/R1 | Em Diagnostic Systems, Inc. | 1993-01-28 | Traditional | PDF ↗ |
| K922231 | OLYMPUS CHOLESTEROL REAGENT | Olympus Corp. | 1992-11-18 | Traditional | PDF ↗ |
| K923733 | CHOLESTEROL TEST | Em Diagnostic Systems, Inc. | 1992-10-26 | Traditional | PDF ↗ |
| K923128 | KING DIAGNOSTICS CHOLESTEROL REAGENT | King Diagnostics, Inc. | 1992-09-09 | Traditional | PDF ↗ |
| K922612 | CHOLESTECH LIPID MONITORING SYSTEM, TOTAL CHOLESTE | Cholestech Corp. | 1992-06-24 | Traditional | PDF ↗ |
| K914160 | CHOLESTEROL REGEANT SET | Tech Intl. Co. | 1992-01-30 | Traditional | PDF ↗ |
| K913565 | ABBOTT QUICKSTART CHOLESTEROL TEST | Em Diagnostic Systems, Inc. | 1991-12-18 | Traditional | PDF ↗ |
| K914469 | CHOLESTECH LIPID MONIT SYST, TOTAL CHOL/TRIG PANEL | Cholestech Corp. | 1991-10-30 | Traditional | PDF ↗ |
| K912499 | KING DIAGNOSTICS CHOLESTEROL REAGENT STRIP TEST | King Diagnostics, Inc. | 1991-09-27 | Traditional | PDF ↗ |
| K912212 | PROACT CHOLESTEROL SYSTEMS | Boehringer Mannheim Corp. | 1991-08-28 | Traditional | PDF ↗ |
| K911692 | ENZYMATICS, INC., TOTAL CHOLESTEROL TEST | Enzymatics C/O Burditt,Bowles,Radzius & Ruberry | 1991-08-16 | Traditional | PDF ↗ |
| K912136 | CHOLESTECH LIPID MONITORING SYS. | Cholestech Corp. | 1991-07-30 | Traditional | PDF ↗ |
| K911578 | CHOLESTECH L.D.X. LIPID ANALYZER, MODIFICATION | Cholestech Corp. | 1991-05-15 | Traditional | PDF ↗ |
| K905405 | CHEMTRAK ACCUMETER CHOLESTEROL TEST | Chemtrak, Inc. | 1991-03-19 | Traditional | PDF ↗ |
| K904031 | CHEMA CHOL CHOLESTEROL SYSTEM | Texas Intl. Laboratories, Inc. | 1991-03-11 | Traditional | PDF ↗ |
| K905648 | CRP LIPID REAGENT TEST PACK | Cirrus Diagnostics, Inc. | 1991-03-06 | Traditional | PDF ↗ |
| K910240 | CHOLESTAT (TM) WHOLE BLOOD CHOLESTEROL TEST | Crystal Diagnostics, Inc. | 1991-02-26 | Traditional | PDF ↗ |
| K905145 | ECLIPSE ICA CHOLESTEROL | Biotope, Inc. | 1991-02-26 | Traditional | PDF ↗ |
| K903126 | CHOLESTAT(TM) WHOLE BLOOD CHOLESTEROL TEST | Crystal Diagnostics, Inc. | 1990-12-26 | Traditional | PDF ↗ |
| K903015 | SYNERMED CHOLESTEROL REAGENT KIT | Synermed, Inc. | 1990-10-01 | Traditional | PDF ↗ |
| K902678 | LIQUID STABLE CHOLESTEROL REAGENT KIT | Trace Scientific , Ltd. | 1990-09-25 | Traditional | PDF ↗ |
| K902098 | CHOLESTEROL (RATE) REAGENT | Sigma Chemical Co. | 1990-08-09 | Traditional | PDF ↗ |
| K901900 | L.D.X LIPID MONITORING SYSTEM | Cholestech Corp. | 1990-07-24 | Traditional | PDF ↗ |
| K896467 | SATELLITE C BLOOD CHOLESTEROL MONITORING SYSTEM | Medisense, Inc. | 1990-06-12 | Traditional | PDF ↗ |
| K897162 | COULTER CHOLESTEROL REAGENT | Coulter Electronics, Inc. | 1990-03-29 | Traditional | PDF ↗ |
| K900850 | EMDS CHOLESTEROL (CHO), ITEM NUMBERS 65410 | Em Diagnostic Systems, Inc. | 1990-03-29 | Traditional | PDF ↗ |
| K897036 | IMMUNOTECH CHOLESTEROL TEST | Immunotech Corp. | 1990-03-06 | Traditional | PDF ↗ |
| K895951 | CHOLESTEROL TEST KIT | Elite Technology, Inc. | 1990-02-16 | Traditional | PDF ↗ |
| K896239 | COBAS READY CHOLESTEROL REAGENT | Roche Diagnostic Systems, Inc. | 1990-02-16 | Traditional | PDF ↗ |
| K896073 | CHOLESTEROL, UNIVERSAL ET | Enzyme Technology, Inc. | 1989-12-12 | Traditional | PDF ↗ |
Product code CHH · Class I · Clinical Chemistry. Data: openFDA.