Submission Details
| 510(k) Number | K033433 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 28, 2003 |
| Decision Date | January 02, 2004 |
| Days to Decision | 66 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
Cleared
Traditional
NOVA GLUCOSE CONTROL SOLUTIONS
Jan 2004
Decision
66d
Days
Class 1
Risk
About This 510(k) Submission
K033433 is an FDA 510(k) clearance for the NOVA GLUCOSE CONTROL SOLUTIONS, a Single (specified) Analyte Controls (assayed And Unassayed) (Class I — General Controls, product code JJX), submitted by Nova Biomedical Corp. (Waltham, US). The FDA issued a Cleared decision on January 2, 2004, 66 days after receiving the submission on October 28, 2003. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.
Device Classification
| Product Code | JJX — Single (specified) Analyte Controls (assayed And Unassayed) |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 862.1660 |
Manufacturer
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