Submission Details
| 510(k) Number | K081908 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 03, 2008 |
| Decision Date | January 16, 2009 |
| Days to Decision | 197 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
Cleared
Traditional
CLINIQA LIQUID QC URINALYSIS CONTROLS, LEVELS 1 AND 2
Jan 2009
Decision
197d
Days
Class 1
Risk
About This 510(k) Submission
K081908 is an FDA 510(k) clearance for the CLINIQA LIQUID QC URINALYSIS CONTROLS, LEVELS 1 AND 2, a Urinalysis Controls (assayed And Unassayed) (Class I — General Controls, product code JJW), submitted by Cliniqa Corporation (San Marcos, US). The FDA issued a Cleared decision on January 16, 2009, 197 days after receiving the submission on July 3, 2008. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.
Device Classification
| Product Code | JJW — Urinalysis Controls (assayed And Unassayed) |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 862.1660 |
Manufacturer
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