Product code CHH
- Device name
- Enzymatic Esterase--Oxidase, Cholesterol
- Medical specialty
- Clinical Chemistry
- Device class
- 1
- Regulation number
- 862.1175
- Review panel
- CH
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251091 | Lipids | Truvian Health | 2025-12-30 |
| K232404 | CHOLESTEROL; HDL-cholesterol ; LDL-cholesterol; TRIGLYCERIDES | Medicon Hellas S.A | 2024-08-09 |
| K203597 | Cholesterol2 | Abbott Ireland Diagnostics Division | 2022-06-30 |
| K190490 | VITROS XT Chemistry Products TRIG-CHOL Slides | Ortho-Clinical Diagnostics, Inc. | 2019-03-27 |
| K181373 | Extended Lipid Panel Assay | Laboratory Corporation of America Holdings | 2018-10-18 |
| K180504 | Mission Lipid Panel Monitoring System | ACON Laboratories, Inc. | 2018-03-28 |
| K163406 | Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring System | ACON Laboratories, Inc. | 2017-07-11 |
| 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 |
| K150654 | Cholesterol | Randox Laboratories, Ltd. | 2015-09-29 |
| K132031 | AFINION LIPID PANEL AND AFINION LIPID PANEL CONTROL | Axis-Shield Poc AS | 2014-03-21 |
| K130200 | PICCOLO TOTAL CHOLESTEROL - CAPILLARY TEST SYSTEM | Abaxis, Inc. | 2013-02-15 |
| K122757 | ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT, ACE TRIGLYCERIDES REAGENT | Alfa Wassermann Diagnostic Technologies, Inc. | 2012-10-05 |
| K120202 | EON CHOLESTEROL REAGENT | Vital Diagnostics Pty., Ltd. | 2012-07-27 |
| K113262 | ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT-C, ACE-TRISLYCERIDES REAGENT | Alfa Wassermann Diagnostic Technologies, Inc. | 2012-07-03 |
| K112538 | ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT, ACE TRIGLYCERIDES REAGENT | Alfa Wassermann Diagnostic Technologies, Inc. | 2012-03-29 |
| K111753 | HITACHI CLINICAL ANALYZER S TEST REAGENT CATRIDGE FOR: CHOLESTROL, HDL, LDL, AND TRIGLYCERIDE | Hitachi Chemical Diagnostics, Inc. | 2011-12-14 |
| K091413 | S-TEST CHOLESTEROL (CHO), MODEL RC0009, S-TEST HDL CHOLESTEROL (HDL), MODEL RC0015, S-TEST TRIGLYCERIDES (TG) | Alfa Wassermann, Inc. | 2009-10-26 |
| K080623 | CHOLESTEROL OXIDASE JASE, AND GLYCEROL INASE TRIGLYCERIDES, MODEL NA | Jas Diagnostics, Inc. | 2008-11-17 |
| K072249 | EASYRA CHOLESTEROL REAGENT; EASYRA CALCIUM REAGENT REAGENT | Medica Corp. | 2008-02-20 |
| K071593 | PTS PANELS CHOL+HDL PANEL TEST STRIPS | Polymer Technology Systems, Inc. | 2007-10-15 |
| K062026 | VAP-NT CHOLESTEROL TEST | Atherotech, Inc. | 2007-03-06 |
| K051376 | ACCUCHEK INSTANT PLUS DUAL TESTING SYSTEM, ACCUCHEK INSTANT PLUS CHOLESTEROL, ACCUCHEK INSTANT PLUS GLUCOCOSE | Roche Diagnostics | 2005-08-23 |
| K042443 | SPOTCHEM HDL, TOTAL CHOLESTEROL AND TRIGLYCERIDE REAGENT TESTS AND PANEL | Arkray, Inc. | 2004-11-24 |
| K031824 | COBAS INTEGRA CHOLESTEROL GEN. 2 | Roche Diagnostics Corp. | 2003-07-09 |
| K023642 | PICCOLO TOTAL CHOLESTEROL TEST SYSTEM | Abaxis, Inc. | 2003-01-24 |
| K023558 | PTS PANELS LIPID PANEL TEST STRIPS | Polymer Technology Systems, Inc. | 2002-11-15 |
| K022898 | PTS PANELS LIPID PANEL TEST STRIPS | Polymer Technology Systems, Inc. | 2002-09-24 |
| K013173 | BIOSCANNER PLUS; LIPID PANEL TEST STRIPS | Polymer Technology Systems, Inc. | 2001-10-22 |
| K011970 | BIOSAFE CHOLESTEROL PROFILE BLOOD COLLECTION AND TRANSPORT SYSTEM | Biosafe Laboratories, Inc. | 2001-09-26 |
| K001032 | RLP-CHOLESTEROL IMMUNOSEPARATION ASSAY | Otsuka Pharmaceutical Co., Ltd. | 2000-07-24 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 06935740725712 | Blood Lipid Analyzer | Urit Medical Electronic Co., Ltd. | 2026-06-03 |
| 06935740725705 | Blood Lipid Analyzer | Urit Medical Electronic Co., Ltd. | 2026-06-03 |
| 00682607690053 | Mission Cholesterol Test Device - 3-in-1 Lipid Panel 25T | Acon Laboratories, Inc. | 2026-03-09 |
| 00381934770017 | Cholesterol | POLYMER TECHNOLOGY SYSTEMS, INC. | 2025-06-16 |
| 00381934753010 | Lipid Panel, 15ct., CCPlus Home | POLYMER TECHNOLOGY SYSTEMS, INC. | 2023-06-20 |
| 00381934752013 | Lipid + eGLU Smart Bundle™ , CC Plus Home (15-pk) | POLYMER TECHNOLOGY SYSTEMS, INC. | 2023-06-01 |
| 00381934749013 | Assy Vial, Lipid Panel Test Strips, 1 ct, CardioChek Plus Home | POLYMER TECHNOLOGY SYSTEMS, INC. | 2023-03-25 |
| 00381934747019 | Assy Vial, Lipid Panel Test Strips, 15 ct, CardioChek Plus Home | POLYMER TECHNOLOGY SYSTEMS, INC. | 2023-03-25 |
| 00381934722016 | CardioChek Plus Home Lipid Panel Self-Test Strip 2ct | POLYMER TECHNOLOGY SYSTEMS, INC. | 2021-02-08 |
| 00381934721019 | CardioChek Plus Home Lipid + eGLU Smart Bundle Self-Test 2ct | POLYMER TECHNOLOGY SYSTEMS, INC. | 2021-02-08 |
| 00381934720012 | CardioChek Plus Home Self-Test Analyzer | POLYMER TECHNOLOGY SYSTEMS, INC. | 2021-02-08 |
| 08809319396161 | CURO L7 Analyzer | SD Biosensor, Inc. | 2020-04-21 |
| 08809319396512 | CURO L7 Lipid Test Strip - Lipid Profile | SD Biosensor, Inc. | 2020-04-21 |
| 10758750031764 | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. | 2019-11-13 |
| 00381932478014 | CardioChek Plus Lipid + eGLU Test Strips Smart Bundle™ (2-pk) | POLYMER TECHNOLOGY SYSTEMS, INC. | 2019-10-15 |
| 00381932470018 | PTS Panels® Lipid Panel Test Strips (10-ct) | POLYMER TECHNOLOGY SYSTEMS, INC. | 2019-10-15 |
| 10763924550507 | LipidPlus® Meter | JANT PHARMACAL CORPORATION | 2017-02-16 |
| 00304040040539 | CardioChek | HENRY SCHEIN, INC. | 2017-01-16 |
| 10304040037741 | CardioChek | HENRY SCHEIN, INC. | 2017-01-05 |
| 10304040037734 | CardioChek | HENRY SCHEIN, INC. | 2017-01-05 |
| 00381932412018 | PTS Panels® CHOL+HDL+GLU Test Strips | POLYMER TECHNOLOGY SYSTEMS, INC. | 2016-07-15 |
| 00381932700016 | CardioChek® Plus Professional Analyzer | POLYMER TECHNOLOGY SYSTEMS, INC. | 2016-07-15 |
| 00381932701013 | CardioChek® Plus Professional Analyzer | POLYMER TECHNOLOGY SYSTEMS, INC. | 2016-07-15 |
| 00381932702010 | CardioChek® Plus Professional Analyzer, Refurbished | POLYMER TECHNOLOGY SYSTEMS, INC. | 2016-07-15 |
| 00381932729017 | CardioChek Plus Lipid + eGLU Test Strips Smart Bundle™ (2-pk) | POLYMER TECHNOLOGY SYSTEMS, INC. | 2016-07-15 |
| 00381931821019 | PTS Panels® CHOL+HDL Test Strips | POLYMER TECHNOLOGY SYSTEMS, INC. | 2016-07-15 |
| 00381931757011 | CardioChek® PA Professional Analyzer, Refurbished | POLYMER TECHNOLOGY SYSTEMS, INC. | 2016-07-15 |
| 00381931710016 | PTS Panels® Lipid Panel Test Strips | POLYMER TECHNOLOGY SYSTEMS, INC. | 2016-07-15 |
| 00381931709010 | CardioChek® Analyzer | POLYMER TECHNOLOGY SYSTEMS, INC. | 2016-07-15 |
| 00381931708013 | CardioChek® PA analyzer | POLYMER TECHNOLOGY SYSTEMS, INC. | 2016-07-15 |