Cleared Traditional

LINICAL ESOTERICS CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER SYNCHRON ANALYZERS

K032074 · Cliniqa Corporation · Chemistry
Oct 2003
Decision
106d
Days
Class 1
Risk

About This 510(k) Submission

K032074 is an FDA 510(k) clearance for the LINICAL ESOTERICS CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER SYNCHRON 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 October 21, 2003, 106 days after receiving the submission on July 7, 2003. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K032074 FDA.gov
FDA Decision Cleared SESE
Date Received July 07, 2003
Decision Date October 21, 2003
Days to Decision 106 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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