Cleared Traditional

LINICAL CHEMISTRY CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEMS

K033162 · Cliniqa Corporation · Chemistry
Oct 2003
Decision
10d
Days
Class 1
Risk

About This 510(k) Submission

K033162 is an FDA 510(k) clearance for the LINICAL CHEMISTRY CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEMS, 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 October 10, 2003, 10 days after receiving the submission on September 30, 2003. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K033162 FDA.gov
FDA Decision Cleared SESE
Date Received September 30, 2003
Decision Date October 10, 2003
Days to Decision 10 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code JJY — Multi-analyte Controls, All Kinds (assayed)
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1660

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