K844998 is an FDA 510(k) clearance for the GLUCOSE(HEXOKINASE) REAGENT SET. This device is classified as a Hexokinase, Glucose (Class II - Special Controls, product code CFR).
Submitted by Sterling Biochemical, Inc. (Dearborn, US). The FDA issued a Cleared decision on January 18, 1985, 23 days after receiving the submission on December 26, 1984.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1345.
| 510(k) Number | K844998 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 26, 1984 |
| Decision Date | January 18, 1985 |
| Days to Decision | 23 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | CFR — Hexokinase, Glucose |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1345 |