Submission Details
| 510(k) Number | K070255 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 26, 2007 |
| Decision Date | June 13, 2007 |
| Days to Decision | 138 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
Cleared
Traditional
NOVA MAX BLOOD GLUCOSE MONITOR SYSTEM, 90001,90002
Jun 2007
Decision
138d
Days
Class 2
Risk
About This 510(k) Submission
K070255 is an FDA 510(k) clearance for the NOVA MAX BLOOD GLUCOSE MONITOR SYSTEM, 90001,90002, a System, Test, Blood Glucose, Over The Counter (Class II — Special Controls, product code NBW), submitted by Nova Biomedical Corp. (Waltham, US). The FDA issued a Cleared decision on June 13, 2007, 138 days after receiving the submission on January 26, 2007. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.
Device Classification
| Product Code | NBW — System, Test, Blood Glucose, Over The Counter |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.1345 |
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