Submission Details
| 510(k) Number | K101633 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 10, 2010 |
| Decision Date | August 27, 2010 |
| Days to Decision | 78 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Traditional
NOVA MAX PLUS GLOCOSE AND B-KETONE CONTROL SOLUTION-MID, HIGH
Aug 2010
Decision
78d
Days
Class 1
Risk
About This 510(k) Submission
K101633 is an FDA 510(k) clearance for the NOVA MAX PLUS GLOCOSE AND B-KETONE CONTROL SOLUTION-MID, HIGH, a Multi-analyte Controls, All Kinds (assayed) (Class I — General Controls, product code JJY), submitted by Nova Biomedical Corp. (Waltham, US). The FDA issued a Cleared decision on August 27, 2010, 78 days after receiving the submission on June 10, 2010. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.
Device Classification
| Product Code | JJY — Multi-analyte Controls, All Kinds (assayed) |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 862.1660 |
Manufacturer
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