The following data is part of a premarket notification filed by Polymer Technology Systems, Inc. D/b/a Pts Diagnostics with the FDA for Pts Professional Chemistry Kit.
| Device ID | K182781 |
| 510k Number | K182781 |
| Device Name: | PTS Professional Chemistry Kit |
| Classification | Glucose Oxidase, Glucose |
| Applicant | Polymer Technology Systems, Inc. D/b/a PTS Diagnostics 7736 Zionsville Road Indianapolis, IN 46268 |
| Contact | Samuel Engelman |
| Correspondent | Samuel Engelman 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 | JGY |
| Subsequent Product Code | LBR |
| Subsequent Product Code | LCP |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-10-01 |
| Decision Date | 2018-12-21 |
| Summary: | summary |