The following data is part of a premarket notification filed by Polymer Technology Systems, Inc. with the FDA for Mtm Bioscanner K Test Strips.
| Device ID | K981865 |
| 510k Number | K981865 |
| Device Name: | MTM BIOSCANNER K TEST STRIPS |
| Classification | Acid, Alpha-ketobutyric And Nadh (u.v.), Hydroxybutyric Dehydrogenase |
| 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 | JMK |
| CFR Regulation Number | 862.1380 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-05-28 |
| Decision Date | 1999-02-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00381931718012 | K981865 | 000 |