Submission Details
| 510(k) Number | K040455 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 23, 2004 |
| Decision Date | March 05, 2004 |
| Days to Decision | 11 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
Cleared
Traditional
LINICAL URIC ACID CALIBRATION VERIFIERS LEVELS A - E FOR OLYMPUS AU SYSTEMS
Mar 2004
Decision
11d
Days
Class 1
Risk
About This 510(k) Submission
K040455 is an FDA 510(k) clearance for the LINICAL URIC ACID CALIBRATION VERIFIERS LEVELS A - E FOR OLYMPUS AU SYSTEMS, a Single (specified) Analyte Controls (assayed And Unassayed) (Class I — General Controls, product code JJX), submitted by Cliniqa Corporation (Fallbrook, US). The FDA issued a Cleared decision on March 5, 2004, 11 days after receiving the submission on February 23, 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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