The following data is part of a premarket notification filed by Polymer Technology Systems, Inc. with the FDA for Cardiochek Plus Test System, Cardiochek Home Test System, Cardiochek Pa Test System, Cardiochek Pa Home Test System.
| Device ID | K151545 |
| 510k Number | K151545 |
| Device Name: | CardioChek Plus Test System, CardioChek Home Test System, CardioChek PA Test System, CardioChek PA Home Test System |
| Classification | Enzymatic Esterase--oxidase, Cholesterol |
| Applicant | POLYMER TECHNOLOGY SYSTEMS, INC. 7736 ZIONSVILLE ROAD Indianapolis, IN 46268 |
| Contact | Margo Enright |
| Correspondent | Margo Enright POLYMER TECHNOLOGY SYSTEMS, INC. 7736 ZIONSVILLE ROAD Indianapolis, IN 46268 |
| Product Code | CHH |
| Subsequent Product Code | JGY |
| Subsequent Product Code | LBR |
| CFR Regulation Number | 862.1175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-06-09 |
| Decision Date | 2016-12-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00381932700016 | K151545 | 000 |
| 00381931710016 | K151545 | 000 |
| 00381931708013 | K151545 | 000 |
| 00381932470018 | K151545 | 000 |
| 10381934722013 | K151545 | 000 |
| 10381934753017 | K151545 | 000 |
| 00381931716018 | K151545 | 000 |