K894394 is an FDA 510(k) clearance for the ABBOTT SPECTRUM GLUCOSE-HEXOKINASE REAGENT. This device is classified as a Hexokinase, Glucose (Class II - Special Controls, product code CFR).
Submitted by Abbott Laboratories (Irving, US). The FDA issued a Cleared decision on October 3, 1989, 78 days after receiving the submission on July 17, 1989.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1345.
| 510(k) Number | K894394 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 17, 1989 |
| Decision Date | October 03, 1989 |
| Days to Decision | 78 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 |