The following data is part of a premarket notification filed by Polymer Technology Systems, Inc. with the FDA for Cardiochek Plus Test System.
| Device ID | K151530 |
| 510k Number | K151530 |
| Device Name: | CardioChek Plus Test System |
| Classification | Glucose Oxidase, Glucose |
| Applicant | POLYMER TECHNOLOGY SYSTEMS, INC. 7736 Zionsville Rd Indianapolis, IN 46268 |
| Contact | Megan Burns |
| Correspondent | Megan Burns POLYMER TECHNOLOGY SYSTEMS, INC. 7736 Zionsville Rd Indianapolis, IN 46268 |
| 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 | 2015-06-08 |
| Decision Date | 2015-07-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00381930860019 | K151530 | 000 |