K972876 is an FDA 510(k) clearance for the GLUCOTREND BASIC SYSTEM. This device is classified as a Glucose Dehydrogenase, Glucose (Class II - Special Controls, product code LFR).
Submitted by Boehringer Mannheim Corp. (Indianapolis, US). The FDA issued a Cleared decision on October 9, 1997, 66 days after receiving the submission on August 4, 1997.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1345.
| 510(k) Number | K972876 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 04, 1997 |
| Decision Date | October 09, 1997 |
| Days to Decision | 66 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | LFR — Glucose Dehydrogenase, Glucose |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1345 |