K063821 is an FDA 510(k) clearance for the NOVA STATSTRIP GLUCOSE HOSPITAL METER SYSTEM. This device is classified as a Glucose Oxidase, Glucose (Class II — Special Controls, product code CGA).
Submitted by Nova Biomedical Corp. (Waltham, US). The FDA issued a Cleared decision on January 24, 2007, 29 days after receiving the submission on December 26, 2006.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1345.
| 510(k) Number | K063821 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 26, 2006 |
| Decision Date | January 24, 2007 |
| Days to Decision | 29 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | CGA — Glucose Oxidase, Glucose |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.1345 |