Submission Details
| 510(k) Number | K041898 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 14, 2004 |
| Decision Date | August 16, 2004 |
| Days to Decision | 33 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
Cleared
Traditional
CLINIQA LIQUID QC TDM CONTROLS LEVELS 1,2 & 3/CLINIQA LINICAL TDM CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEM
Aug 2004
Decision
33d
Days
Class 1
Risk
About This 510(k) Submission
K041898 is an FDA 510(k) clearance for the CLINIQA LIQUID QC TDM CONTROLS LEVELS 1,2 & 3/CLINIQA LINICAL TDM CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEM, 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 August 16, 2004, 33 days after receiving the submission on July 14, 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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