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.
| Device ID | K140068 |
| 510k Number | K140068 |
| Device Name: | CARDIOCHEK PLUS TEST SYSTEM, CARDIOCHEK HOME TEST SYSTEM |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | POLYMER TECHNOLOGY SYSTEMS, INC. 7736 Zionsville Rd Indianapolis, IN 46268 |
| Contact | Margo Enright |
| Correspondent | Margo Enright POLYMER TECHNOLOGY SYSTEMS, INC. 7736 Zionsville Rd Indianapolis, IN 46268 |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-01-13 |
| Decision Date | 2015-05-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00381932728010 | K140068 | 000 |
| 10304040037727 | K140068 | 000 |
| 10381934723010 | K140068 | 000 |
| 00381932471015 | K140068 | 000 |
| 90304040038522 | K140068 | 000 |
| 00304040037713 | K140068 | 000 |
| 00381932701013 | K140068 | 000 |
| 00381932702010 | K140068 | 000 |
| 00381932713016 | K140068 | 000 |
| 10381934755011 | K140068 | 000 |