K781945 is an FDA 510(k) clearance for the GLUCOSE OXIDASE REAGENT. This device is classified as a Glucose Oxidase, Glucose (Class II - Special Controls, product code CGA).
Submitted by Fermco Biochemics, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 17, 1979, 57 days after receiving the submission on November 21, 1978.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1345.
| 510(k) Number | K781945 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 21, 1978 |
| Decision Date | January 17, 1979 |
| Days to Decision | 57 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | CGA — Glucose Oxidase, Glucose |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1345 |