K812303 is an FDA 510(k) clearance for the GLUCOSE-HK SYSTEM PACK TEST. This device is classified as a Hexokinase, Glucose (Class II - Special Controls, product code CFR).
Submitted by Boehringer Mannheim Corp. (Mchenry, US). The FDA issued a Cleared decision on September 1, 1981, 14 days after receiving the submission on August 18, 1981.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1345.
| 510(k) Number | K812303 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 18, 1981 |
| Decision Date | September 01, 1981 |
| Days to Decision | 14 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 |