K070960 is an FDA 510(k) clearance for the NOVA STATSTRIP XPRESS 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 July 11, 2007, 97 days after receiving the submission on April 5, 2007.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1345.
| 510(k) Number | K070960 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 05, 2007 |
| Decision Date | July 11, 2007 |
| Days to Decision | 97 days |
| Submission Type | Special |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | CGA — Glucose Oxidase, Glucose |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1345 |