LINICAL PROTEIN 3 CALIBRATION VERIFIERS LEVELS A-E FOR THE OLYMPUS AU SERIES CHEMISTRY IMMUNO ANALYZERS

About This 510(k) Submission

K030566 is an FDA 510(k) clearance for the LINICAL PROTEIN 3 CALIBRATION VERIFIERS LEVELS A-E FOR THE OLYMPUS AU SERIES CHEMISTRY IMMUNO ANALYZERS, a Multi-analyte Controls, All Kinds (assayed) (Class I — General Controls, product code JJY), submitted by Cliniqa Corporation (Fallbrook, US). The FDA issued a Cleared decision on March 13, 2003, 17 days after receiving the submission on February 24, 2003. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.