K912251 is an FDA 510(k) clearance for the KING DIAGNOSTICS GLUCOSE (HK) REAGENT STRIP TEST. This device is classified as a Hexokinase, Glucose (Class II - Special Controls, product code CFR).
Submitted by King Diagnostics, Inc. (Indianapolis, US). The FDA issued a Cleared decision on July 18, 1991, 58 days after receiving the submission on May 21, 1991.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1345.
| 510(k) Number | K912251 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 21, 1991 |
| Decision Date | July 18, 1991 |
| Days to Decision | 58 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | CFR — Hexokinase, Glucose |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1345 |