Submission Details
| 510(k) Number | K091547 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 27, 2009 |
| Decision Date | January 15, 2010 |
| Days to Decision | 233 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Traditional
NOVA MAX PLUS BLOOD GLUCOSE AND B-KETONE MONITOR SYSTEM, NOVA MAX PLUS B-KETONE CONTROL SOLUTIONS, NOVA MAX BLOOD GLUCOS
Jan 2010
Decision
233d
Days
Class 2
Risk
About This 510(k) Submission
K091547 is an FDA 510(k) clearance for the NOVA MAX PLUS BLOOD GLUCOSE AND B-KETONE MONITOR SYSTEM, NOVA MAX PLUS B-KETONE CONTROL SOLUTIONS, NOVA MAX BLOOD GLUCOS, 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 January 15, 2010, 233 days after receiving the submission on May 27, 2009. 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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