K972669 is an FDA 510(k) clearance for the MTM BIOSCANNER 1000 TEST SYSTEM CONSISTING OF MTM BIOSCANNER 1000 METER, MTM BIOSCANNER G TEST STRIP, NORMAN GLUCOSE CON. This device is classified as a Glucose Oxidase, Glucose (Class II - Special Controls, product code CGA).
Submitted by Polymer Technology Systems, Inc. (Indianapolis, US). The FDA issued a Cleared decision on January 22, 1998, 190 days after receiving the submission on July 16, 1997.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1345.
| 510(k) Number | K972669 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 16, 1997 |
| Decision Date | January 22, 1998 |
| Days to Decision | 190 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | CGA - Glucose Oxidase, Glucose |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1345 |