K971467 is an FDA 510(k) clearance for the SYNCHRON CX SYSTEMS GLUCOSE REAGENT (GLU). This device is classified as a Hexokinase, Glucose (Class II - Special Controls, product code CFR).
Submitted by Carolina Liquid Chemistries Corp. (Brea, US). The FDA issued a Cleared decision on June 16, 1997, 55 days after receiving the submission on April 22, 1997.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1345.
| 510(k) Number | K971467 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 22, 1997 |
| Decision Date | June 16, 1997 |
| Days to Decision | 55 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 |