510(k) K151545
- Device
- CardioChek Plus Test System, CardioChek Home Test System, CardioChek PA Test System, CardioChek PA Home Test System
- Applicant
- POLYMER TECHNOLOGY SYSTEMS, INC.
- 510(k) number
- K151545
- Product code
- CHH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2016-12-22
- Date received
- 2015-06-09
- Regulation
- 862.1175
- Classification name
- Enzymatic Esterase--oxidase, Cholesterol
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- MARGO ENRIGHT
- Address
- 7736 Zionsville Rd. Indianapolis IN US 46268 46268
FDA Registration Numbers#
- 2030861
- 3007134734
- 3023197868
- 3006198300
- 3013660430
- 3010825766
- 1219029
- 3012133212
- 1000455123
- 1717966
- 3014325803
- 3013654096
- 3004145393
- 2050010
- 2030633
- 3020978007
- 3006716639
- 3016438761
- 3002736372
- 1649661
- 3000308930
- 2027969
- 3023162659
- 3016859940
- 1220972
- 3000148879
- 3005094123
- 3003593973
- 1825396
- 3003795116
- 3010891909
- 3021186226
- 3017379203
- 1832216
- 3021841051
- 3020885868
- 3008959444
- 2432235
- 8040374
- 3004192065
- 8020316
- 3021010433
- 3005644014
- 3005333358
- 3004493545
- 9680746
- 3011989923
- 2085064
- 1616487
- 3011061417
- 3002809144
- 3002642396
- 1319809
- 1181121
- 3008517993
- 3012963943
- 1423455
- 2250051
- 2247288
- 2050012
- 9613069
- 3010830834
- 9610529
- 3015413132
- 2531491
- 3008959428
- 2517506
- 9615507
- 3004146366
- 3011979858
- 3004193489
- 3003902721
- 3003366417
- 9610126
- 1036362
- 2939693
- 3015525148
- 1827821
- 3008877272
- 1063851
Source Documents#
Other 510(k) Records For Product Code CHH #
| 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 |
| 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 |
Legacy Summary#
summary
FDA Review#
Decision Summary