The following data is part of a premarket notification filed by Polymer Technology Systems, Inc. D/b/a Pts Diagnostics with the FDA for Cardiochek Plus Test System, Cardiochek Home Test System.
| Device ID | K162282 |
| 510k Number | K162282 |
| Device Name: | CardioChek Plus Test System, CardioChek Home Test System |
| Classification | Glucose Oxidase, Glucose |
| Applicant | Polymer Technology Systems, Inc. D/b/a PTS Diagnostics 7736 Zionsville Road Indianapolis, IN 46268 |
| Contact | Margo Enright |
| Correspondent | Margo Enright Polymer Technology Systems, Inc. D/b/a PTS Diagnostics 7736 Zionsville Road Indianapolis, IN 46268 |
| Product Code | CGA |
| Subsequent Product Code | CHH |
| Subsequent Product Code | LBR |
| Subsequent Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-15 |
| Decision Date | 2016-12-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00381932412018 | K162282 | 000 |
| 00381931821019 | K162282 | 000 |
| 00381931765016 | K162282 | 000 |
| 00381932477017 | K162282 | 000 |
| 00381932469012 | K162282 | 000 |