K855153 is an FDA 510(k) clearance for the GLUCOSE (UV HEXOKIASE) REAGENT SET. This device is classified as a Hexokinase, Glucose (Class II - Special Controls, product code CFR).
Submitted by Technostics Intl. (Washington, US). The FDA issued a Cleared decision on January 14, 1986, 19 days after receiving the submission on December 26, 1985.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1345.
| 510(k) Number | K855153 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 26, 1985 |
| Decision Date | January 14, 1986 |
| Days to Decision | 19 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 |