The following data is part of a premarket notification filed by Polymer Technology Systems, Inc. with the FDA for Mtm Bioscanner 1000 Test System Consisting Of Mtm Bioscanner 1000 Meter, Mtm Bioscanner G Test Strip, Norman Glucose Con.
| Device ID | K972669 |
| 510k Number | K972669 |
| Device Name: | MTM BIOSCANNER 1000 TEST SYSTEM CONSISTING OF MTM BIOSCANNER 1000 METER, MTM BIOSCANNER G TEST STRIP, NORMAN GLUCOSE CON |
| Classification | Glucose Oxidase, Glucose |
| Applicant | POLYMER TECHNOLOGY SYSTEMS, INC. 7736 ZIONSVILLE RD. Indianapolis, IN 46268 |
| Contact | James M Connolly |
| Correspondent | James M Connolly POLYMER TECHNOLOGY SYSTEMS, INC. 7736 ZIONSVILLE RD. Indianapolis, IN 46268 |
| Product Code | CGA |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-07-16 |
| Decision Date | 1998-01-22 |