The following data is part of a premarket notification filed by Polymer Technology Systems, Inc. with the FDA for Pts Panels Metabolic Chemistry Panel Test Strips.
| Device ID | K070017 |
| 510k Number | K070017 |
| Device Name: | PTS PANELS METABOLIC CHEMISTRY PANEL TEST STRIPS |
| 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 | JGY |
| Subsequent Product Code | LBR |
| Subsequent Product Code | NAQ |
| Subsequent Product Code | NGO |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-01-03 |
| Decision Date | 2007-01-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00381932400015 | K070017 | 000 |