K953210 is an FDA 510(k) clearance for the GLUCOSE (HEXOKINASE) KIT. This device is classified as a Hexokinase, Glucose (Class II - Special Controls, product code CFR).
Submitted by Randox Laboratories, Ltd. (Crumlin, IE). The FDA issued a Cleared decision on October 25, 1996, 473 days after receiving the submission on July 10, 1995.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1345.
| 510(k) Number | K953210 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 10, 1995 |
| Decision Date | October 25, 1996 |
| Days to Decision | 473 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 |