Atlas FDA

CHH

230 FDA 510(k) clearances · Product code

51 daysmedian time to decision
196 days90th percentile
230clearances measured

FDA profile

Official device name
Enzymatic Esterase--Oxidase, Cholesterol
Device class
Class I (low risk)
Regulation
21 CFR 862.1175
Medical specialty
Clinical Chemistry
Adverse events (MAUDE)
2003: 1 · 2010: 10 · 2011: 18 · 2012: 11 · 2026: 17
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Lipids (K251091)Truvian Health2025-12-30
CHOLESTEROL; HDL-cholesterol ; LDL-cholesterol; TRIGLYCERIDES (K232404)Medicon Hellas S.A2024-08-09
Cholesterol2 (K203597)Abbott Ireland Diagnostics Division2022-06-30
VITROS XT Chemistry Products TRIG-CHOL Slides (K190490)Ortho-Clinical Diagnostics, Inc.2019-03-27
Extended Lipid Panel Assay (K181373)Laboratory Corporation of America Holdings2018-10-18
Mission Lipid Panel Monitoring System (K180504)ACON Laboratories, Inc.2018-03-28
Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring System (K163406)ACON Laboratories, Inc.2017-07-11
CardioChek Plus Test System, CardioChek Home Test System, CardioChek PA Test System, CardioChek PA Home Test System (K151545)Polymer Technology Systems, Inc.2016-12-22
Cholesterol (K150654)Randox Laboratories, Ltd.2015-09-29
AFINION LIPID PANEL AND AFINION LIPID PANEL CONTROL (K132031)Axis-Shield Poc AS2014-03-21
PICCOLO TOTAL CHOLESTEROL - CAPILLARY TEST SYSTEM (K130200)Abaxis, Inc.2013-02-15
ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT, ACE TRIGLYCERIDES REAGENT (K122757)Alfa Wassermann Diagnostic Technologies, Inc.2012-10-05
EON CHOLESTEROL REAGENT (K120202)Vital Diagnostics Pty., Ltd.2012-07-27
ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT-C, ACE-TRISLYCERIDES REAGENT (K113262)Alfa Wassermann Diagnostic Technologies, Inc.2012-07-03
ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT, ACE TRIGLYCERIDES REAGENT (K112538)Alfa Wassermann Diagnostic Technologies, Inc.2012-03-29
HITACHI CLINICAL ANALYZER S TEST REAGENT CATRIDGE FOR: CHOLESTROL, HDL, LDL, AND TRIGLYCERIDE (K111753)Hitachi Chemical Diagnostics, Inc.2011-12-14
S-TEST CHOLESTEROL (CHO), MODEL RC0009, S-TEST HDL CHOLESTEROL (HDL), MODEL RC0015, S-TEST TRIGLYCERIDES (TG) (K091413)Alfa Wassermann, Inc.2009-10-26
CHOLESTEROL OXIDASE JASE, AND GLYCEROL INASE TRIGLYCERIDES, MODEL NA (K080623)Jas Diagnostics, Inc.2008-11-17
EASYRA CHOLESTEROL REAGENT; EASYRA CALCIUM REAGENT REAGENT (K072249)Medica Corp.2008-02-20
PTS PANELS CHOL+HDL PANEL TEST STRIPS (K071593)Polymer Technology Systems, Inc.2007-10-15
VAP-NT CHOLESTEROL TEST (K062026)Atherotech, Inc.2007-03-06
ACCUCHEK INSTANT PLUS DUAL TESTING SYSTEM, ACCUCHEK INSTANT PLUS CHOLESTEROL, ACCUCHEK INSTANT PLUS GLUCOCOSE (K051376)Roche Diagnostics2005-08-23
SPOTCHEM HDL, TOTAL CHOLESTEROL AND TRIGLYCERIDE REAGENT TESTS AND PANEL (K042443)Arkray, Inc.2004-11-24
COBAS INTEGRA CHOLESTEROL GEN. 2 (K031824)Roche Diagnostics Corp.2003-07-09
PICCOLO TOTAL CHOLESTEROL TEST SYSTEM (K023642)Abaxis, Inc.2003-01-24
PTS PANELS LIPID PANEL TEST STRIPS (K023558)Polymer Technology Systems, Inc.2002-11-15
PTS PANELS LIPID PANEL TEST STRIPS (K022898)Polymer Technology Systems, Inc.2002-09-24
BIOSCANNER PLUS; LIPID PANEL TEST STRIPS (K013173)Polymer Technology Systems, Inc.2001-10-22
BIOSAFE CHOLESTEROL PROFILE BLOOD COLLECTION AND TRANSPORT SYSTEM (K011970)Biosafe Laboratories, Inc.2001-09-26
RLP-CHOLESTEROL IMMUNOSEPARATION ASSAY (K001032)Otsuka Pharmaceutical Co., Ltd.2000-07-24
RESOLUTION CHOLESTEROL MONITOR (K000610)Lifestream Technologies, Inc.2000-07-21
ATAC PAK CHOLESTEROL REAGENT AND ATAC CALLIBRATOR KITS (K000900)Elan Holdings, Inc.2000-05-02
PRIVALINK SOFTWARE ACCESSORY TO THE LIFESTREAM CHOLESTEROL MONITOR (K993096)Lifestream Technologies, Inc.1999-12-20
SIGMA DIAGNOSTICS INFINITY CHOLESTEROL REAGENT, MODELS 401-25, 401-100P, 401-500P, 401-2000P, 402-20, 02-1OOP (K992803)Sigma Diagnostics, Inc.1999-09-13
CHOLESITE TEST SYSTEM (K992132)Gds Technology, LLC1999-08-20
RLP CHOLESTEROL IMMUNOSEPARATION ASSAY (K991083)Otsuka Pharmaceutical Co., Ltd.1999-08-20
MTM BIOSCANNER C TEST STRIPS (K990688)Polymer Technology Systems, Inc.1999-06-24
CHOLESTRON PRO II CHOLESTEROL TEST (K981345)Lifestream Diagnostics, Inc.1998-10-01
HICHEM CHOLESTEROL REAGENT KIT (K982469)Elan Pharma, Inc.1998-08-19
ENA-C-T TOTAL CHOLESTEROL TEST MODEL F 20000, (PHYSICIAN DIRECTED USE) (K981181)Actimed Laboratories, Inc.1998-08-03
CARESIDE ANALYZER (K982118)Exigent Diagnostics, Inc.1998-07-24
MTM BIOSCANNER C TEST STRIPS MODEL NUMBER BSA 200, BSA 210, BSA 220 (K981493)Polymer Technology Systems, Inc.1998-07-22
CHOL (K981652)Abbott Laboratories1998-06-29
CHOL (K981476)Abbott Laboratories1998-06-25
INFINITY CHOLESTEROL REAGENT (PROCEDURE NO. 401) (K980667)Sigma Diagnostics, Inc.1998-04-21
COBAS INTEGRA HDL-CHOLESTEROL DIRECT (K973284)Roche Diagnostic Systems, Inc.1997-12-18
CHOLESTEROL RAPID LIQUID REAGENT (K972853)Reagents Applications, Inc.1997-09-24
CHOLESTEROL REAGENT (K971072)Derma Media Lab., Inc.1997-06-20
SYNCHRON SYSTEMS CHOLESTEROL (CHOL) REAGENT (K971505)Beckman Instruments, Inc.1997-06-11
PARAMAX CHOLESTEROL REAGENT (K964660)Dade Intl., Inc.1997-06-04
CHOL OR CHOLESTEROL (K971345)Carolina Liquid Chemistries Corp.1997-05-29
CHOLESTEROL-INCORPORATING DYNAMIC STAB TECH (DST) (K962890)Trace Scientific , Ltd.1996-09-27
ENA-C-T TOTAL CHOLESTEROL TEST (K960377)Actimed Laboratories, Inc.1996-05-02
ACCU-CHEK INSTANT PLUS CHOLOESTEROL TEST (K944458)Boehringer Mannheim Corp.1996-03-06
DMA TOTAL CHOLESTEROL PROCEDURE (K946161)Data Medical Associates, Inc.1995-08-23
BOEHRINGER MANNHEIM CHOLESTEROL ASSAY (K952127)Boehringer Mannheim Corp.1995-07-20
PICCOLO(TM) PRIMARY HEALTH PANEL REAGENT ROTOR (K950164)Abaxis, Inc.1995-04-13
CHEM TRAK ACCUMETER (K943599)Chemtrak, Inc.1995-03-21
TOTAL CHOLESTEROL, HDL CHOLESTEROL AND GLUCOSE PANEL (K946066)Cholestech Corp.1995-02-22
TOTAL CHOLESTEROLM HDL CHOLESTEROL AND TRIGLYCERIDES PANEL (K946065)Cholestech Corp.1995-02-22
TOTAL CHOLESTEROL AND HDL CHOLESTEROL PANEL (K946063)Cholestech Corp.1995-02-22
TOTAL CHOLESTEROL, HDL CHOLESTEROL, TRIGLYCERIDES AND GLUCOSE PANEL (K946067)Cholestech Corp.1995-02-22
TOTAL CHOLESTEROL CASSETTE (K946064)Cholestech Corp.1995-02-22
CHOLESTEROL QVET (K943027)Prisma Systems1995-01-27
ROCHE REAGENT (K941573)Roche Diagnostic Systems, Inc.1994-10-31
CHOLESTEROL ENZYMATIC ENDPOINT (K923504)Randox Laboratories, Ltd.1994-01-10
CHOLESTEROL (CHOL) TEST ITEM NO. 65410 (K935136)Em Diagnostic Systems, Inc.1993-12-16
BECKMAN CHOLESTEROL REAGENT (K934046)Beckman-Diagnostic Systems Group1993-10-28
ACCUMETER(R) CHOLESTEROL SELF-TEST (K914432)Chemtrak, Inc.1993-03-02
OLYMPUS CHOLESTEROL REAGENT (K925603)Olympus Corp.1993-02-08
CHOLESTEROL TEST ITEM# 42374/93, 42322/R1 (K924508)Em Diagnostic Systems, Inc.1993-01-28
OLYMPUS CHOLESTEROL REAGENT (K922231)Olympus Corp.1992-11-18
CHOLESTEROL TEST (K923733)Em Diagnostic Systems, Inc.1992-10-26
KING DIAGNOSTICS CHOLESTEROL REAGENT (K923128)King Diagnostics, Inc.1992-09-09
CHOLESTECH LIPID MONITORING SYSTEM, TOTAL CHOLESTE (K922612)Cholestech Corp.1992-06-24
CHOLESTEROL REGEANT SET (K914160)Tech Intl. Co.1992-01-30
ABBOTT QUICKSTART CHOLESTEROL TEST (K913565)Em Diagnostic Systems, Inc.1991-12-18
CHOLESTECH LIPID MONIT SYST, TOTAL CHOL/TRIG PANEL (K914469)Cholestech Corp.1991-10-30
KING DIAGNOSTICS CHOLESTEROL REAGENT STRIP TEST (K912499)King Diagnostics, Inc.1991-09-27
PROACT CHOLESTEROL SYSTEMS (K912212)Boehringer Mannheim Corp.1991-08-28
ENZYMATICS, INC., TOTAL CHOLESTEROL TEST (K911692)Enzymatics C/O Burditt,Bowles,Radzius & Ruberry1991-08-16
CHOLESTECH LIPID MONITORING SYS. (K912136)Cholestech Corp.1991-07-30
CHOLESTECH L.D.X. LIPID ANALYZER, MODIFICATION (K911578)Cholestech Corp.1991-05-15
CHEMTRAK ACCUMETER CHOLESTEROL TEST (K905405)Chemtrak, Inc.1991-03-19
CHEMA CHOL CHOLESTEROL SYSTEM (K904031)Texas Intl. Laboratories, Inc.1991-03-11
CRP LIPID REAGENT TEST PACK (K905648)Cirrus Diagnostics, Inc.1991-03-06
ECLIPSE ICA CHOLESTEROL (K905145)Biotope, Inc.1991-02-26
CHOLESTAT (TM) WHOLE BLOOD CHOLESTEROL TEST (K910240)Crystal Diagnostics, Inc.1991-02-26
CHOLESTAT(TM) WHOLE BLOOD CHOLESTEROL TEST (K903126)Crystal Diagnostics, Inc.1990-12-26
SYNERMED CHOLESTEROL REAGENT KIT (K903015)Synermed, Inc.1990-10-01
LIQUID STABLE CHOLESTEROL REAGENT KIT (K902678)Trace Scientific , Ltd.1990-09-25
CHOLESTEROL (RATE) REAGENT (K902098)Sigma Chemical Co.1990-08-09
L.D.X LIPID MONITORING SYSTEM (K901900)Cholestech Corp.1990-07-24
SATELLITE C BLOOD CHOLESTEROL MONITORING SYSTEM (K896467)Medisense, Inc.1990-06-12
COULTER CHOLESTEROL REAGENT (K897162)Coulter Electronics, Inc.1990-03-29
EMDS CHOLESTEROL (CHO), ITEM NUMBERS 65410 (K900850)Em Diagnostic Systems, Inc.1990-03-29
IMMUNOTECH CHOLESTEROL TEST (K897036)Immunotech Corp.1990-03-06
CHOLESTEROL TEST KIT (K895951)Elite Technology, Inc.1990-02-16
COBAS READY CHOLESTEROL REAGENT (K896239)Roche Diagnostic Systems, Inc.1990-02-16
CHOLESTEROL, UNIVERSAL ET (K896073)Enzyme Technology, Inc.1989-12-12
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Every clearance here is in the API, with alerts when new ones post.