FDA 510(k) Applications for Medical Device Product Code "CHH"
(Enzymatic Esterase--Oxidase, Cholesterol)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K130200 | ABAXIS, INC. | PICCOLO TOTAL CHOLESTEROL - CAPILLARY TEST SYSTEM | 02/15/2013 |
| K023642 | ABAXIS, INC. | PICCOLO TOTAL CHOLESTEROL TEST SYSTEM | 01/24/2003 |
| K203597 | Abbott Ireland Diagnostics Division | Cholesterol2 | 06/30/2022 |
| K981476 | ABBOTT LABORATORIES | CHOL | 06/25/1998 |
| K981652 | ABBOTT LABORATORIES | CHOL | 06/29/1998 |
| K163406 | ACON LABORATORIES INC. | Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring System | 07/11/2017 |
| K180504 | ACON Laboratories, Inc. | Mission Lipid Panel Monitoring System | 03/28/2018 |
| K960377 | ACTIMED LABORATORIES, INC. | ENA-C-T TOTAL CHOLESTEROL TEST | 05/02/1996 |
| K981181 | ACTIMED LABORATORIES, INC. | ENA-C-T TOTAL CHOLESTEROL TEST MODEL F 20000, (PHYSICIAN DIRECTED USE) | 08/03/1998 |
| K113262 | ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. | ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT-C, ACE-TRISLYCERIDES REAGENT | 07/03/2012 |
| K112538 | ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. | ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT, ACE TRIGLYCERIDES REAGENT | 03/29/2012 |
| K122757 | ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. | ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT, ACE TRIGLYCERIDES REAGENT | 10/05/2012 |
| K091413 | ALFA WASSERMANN, INC. | S-TEST CHOLESTEROL (CHO), MODEL RC0009, S-TEST HDL CHOLESTEROL (HDL), MODEL RC0015, S-TEST TRIGLYCERIDES (TG) | 10/26/2009 |
| K042443 | ARKRAY, INC. | SPOTCHEM HDL, TOTAL CHOLESTEROL AND TRIGLYCERIDE REAGENT TESTS AND PANEL | 11/24/2004 |
| K062026 | ATHEROTECH, INC. | VAP-NT CHOLESTEROL TEST | 03/06/2007 |
| K132031 | AXIS-SHIELD POC AS | AFINION LIPID PANEL AND AFINION LIPID PANEL CONTROL | 03/21/2014 |
| K971505 | BECKMAN INSTRUMENTS, INC. | SYNCHRON SYSTEMS CHOLESTEROL (CHOL) REAGENT | 06/11/1997 |
| K011970 | BIOSAFE LABORATORIES, INC. | BIOSAFE CHOLESTEROL PROFILE BLOOD COLLECTION AND TRANSPORT SYSTEM | 09/26/2001 |
| K944458 | BOEHRINGER MANNHEIM CORP. | ACCU-CHEK INSTANT PLUS CHOLOESTEROL TEST | 03/06/1996 |
| K971345 | CAROLINA LIQUID CHEMISTRIES CORP. | CHOL OR CHOLESTEROL | 05/29/1997 |
| K964660 | DADE INTL., INC. | PARAMAX CHOLESTEROL REAGENT | 06/04/1997 |
| K971072 | DERMA MEDIA LAB., INC. | CHOLESTEROL REAGENT | 06/20/1997 |
| K000900 | ELAN HOLDINGS, INC. | ATAC PAK CHOLESTEROL REAGENT AND ATAC CALLIBRATOR KITS | 05/02/2000 |
| K982469 | ELAN PHARMA, INC. | HICHEM CHOLESTEROL REAGENT KIT | 08/19/1998 |
| K982118 | EXIGENT DIAGNOSTICS, INC. | CARESIDE ANALYZER | 07/24/1998 |
| K992132 | GDS TECHNOLOGY, LLC. | CHOLESITE TEST SYSTEM | 08/20/1999 |
| K111753 | HITACHI CHEMICAL DIAGNOSTICS, INC. | HITACHI CLINICAL ANALYZER S TEST REAGENT CATRIDGE FOR: CHOLESTROL, HDL, LDL, AND TRIGLYCERIDE | 12/14/2011 |
| K080623 | JAS Diagnostics, Inc. | CHOLESTEROL OXIDASE JASE, AND GLYCEROL INASE TRIGLYCERIDES, MODEL NA | 11/17/2008 |
| K181373 | Laboratory Corporation of America Holdings | Extended Lipid Panel Assay | 10/18/2018 |
| K981345 | LIFESTREAM DIAGNOSTICS, INC. | CHOLESTRON PRO II CHOLESTEROL TEST | 10/01/1998 |
| K993096 | LIFESTREAM TECHNOLOGIES, INC. | PRIVALINK SOFTWARE ACCESSORY TO THE LIFESTREAM CHOLESTEROL MONITOR | 12/20/1999 |
| K000610 | LIFESTREAM TECHNOLOGIES, INC. | RESOLUTION CHOLESTEROL MONITOR | 07/21/2000 |
| K072249 | MEDICA CORP. | EASYRA CHOLESTEROL REAGENT; EASYRA CALCIUM REAGENT REAGENT | 02/20/2008 |
| K190490 | Ortho-Clinical Diagnostics, Inc. | VITROS XT Chemistry Products TRIG-CHOL Slides | 03/27/2019 |
| K991083 | OTSUKA PHARMACEUTICAL CO., LTD. | RLP CHOLESTEROL IMMUNOSEPARATION ASSAY | 08/20/1999 |
| K001032 | OTSUKA PHARMACEUTICAL CO., LTD. | RLP-CHOLESTEROL IMMUNOSEPARATION ASSAY | 07/24/2000 |
| K013173 | POLYMER TECHNOLOGY SYSTEMS, INC. | BIOSCANNER PLUS; LIPID PANEL TEST STRIPS | 10/22/2001 |
| K151545 | POLYMER TECHNOLOGY SYSTEMS, INC. | CardioChek Plus Test System, CardioChek Home Test System, CardioChek PA Test System, CardioChek PA Home Test System | 12/22/2016 |
| K990688 | POLYMER TECHNOLOGY SYSTEMS, INC. | MTM BIOSCANNER C TEST STRIPS | 06/24/1999 |
| K981493 | POLYMER TECHNOLOGY SYSTEMS, INC. | MTM BIOSCANNER C TEST STRIPS MODEL NUMBER BSA 200, BSA 210, BSA 220 | 07/22/1998 |
| K071593 | POLYMER TECHNOLOGY SYSTEMS, INC. | PTS PANELS CHOL+HDL PANEL TEST STRIPS | 10/15/2007 |
| K022898 | POLYMER TECHNOLOGY SYSTEMS, INC. | PTS PANELS LIPID PANEL TEST STRIPS | 09/24/2002 |
| K023558 | POLYMER TECHNOLOGY SYSTEMS, INC. | PTS PANELS LIPID PANEL TEST STRIPS | 11/15/2002 |
| K150654 | RANDOX LABORATORIES, LTD. | Cholesterol | 09/29/2015 |
| K972853 | REAGENTS APPLICATIONS, INC. | CHOLESTEROL RAPID LIQUID REAGENT | 09/24/1997 |
| K973284 | ROCHE DIAGNOSTIC SYSTEMS, INC. | COBAS INTEGRA HDL-CHOLESTEROL DIRECT | 12/18/1997 |
| K051376 | Roche Diagnostics | ACCUCHEK INSTANT PLUS DUAL TESTING SYSTEM, ACCUCHEK INSTANT PLUS CHOLESTEROL, ACCUCHEK INSTANT PLUS GLUCOCOSE | 08/23/2005 |
| K031824 | ROCHE DIAGNOSTICS CORP. | COBAS INTEGRA CHOLESTEROL GEN. 2 | 07/09/2003 |
| K980667 | SIGMA DIAGNOSTICS, INC. | INFINITY CHOLESTEROL REAGENT (PROCEDURE NO. 401) | 04/21/1998 |
| K992803 | SIGMA DIAGNOSTICS, INC. | SIGMA DIAGNOSTICS INFINITY CHOLESTEROL REAGENT, MODELS 401-25, 401-100P, 401-500P, 401-2000P, 402-20, 02-1OOP | 09/13/1999 |
| K962890 | TRACE SCIENTIFIC LTD. | CHOLESTEROL-INCORPORATING DYNAMIC STAB TECH (DST) | 09/27/1996 |
| K120202 | VITAL DIAGNOSTICS PTY. LTD | EON CHOLESTEROL REAGENT | 07/27/2012 |
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