Submission Details
| 510(k) Number | K041016 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 20, 2004 |
| Decision Date | May 07, 2004 |
| Days to Decision | 17 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
Cleared
Traditional
NOVA GLUCOSE LOW/HIGH LEVEL CONTROL SOLUTIONS
May 2004
Decision
17d
Days
Class 1
Risk
About This 510(k) Submission
K041016 is an FDA 510(k) clearance for the NOVA GLUCOSE LOW/HIGH LEVEL 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 May 7, 2004, 17 days after receiving the submission on April 20, 2004. 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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