K993837 is an FDA 510(k) clearance for the AVL OPTI CRITICAL CARE ANALYZER. This device is classified as a Glucose Oxidase, Glucose (Class II - Special Controls, product code CGA).
Submitted by Avl Scientific Corp. (Roswell, US). The FDA issued a Cleared decision on December 16, 1999, 34 days after receiving the submission on November 12, 1999.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1345.
| 510(k) Number | K993837 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 12, 1999 |
| Decision Date | December 16, 1999 |
| Days to Decision | 34 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | CGA — Glucose Oxidase, Glucose |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1345 |