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 Plus Home Test System.
| Device ID | K193406 |
| 510k Number | K193406 |
| Device Name: | CardioChek Plus Test System; CardioChek Plus Home Test System |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | Polymer Technology Systems, Inc. D/b/a PTS Diagnostics 4600 Anson Boulevard Whitestown, IN 46075 |
| Contact | Margo Enright |
| Correspondent | Margo Enright Polymer Technology Systems, Inc. D/b/a PTS Diagnostics 4600 Anson Boulevard Whitestown, IN 46075 |
| Product Code | NBW |
| Subsequent Product Code | CGA |
| Subsequent Product Code | CHH |
| Subsequent Product Code | JGY |
| Subsequent Product Code | LBR |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-09 |
| Decision Date | 2022-02-26 |