Cleared Traditional

LINICAL CHEMISTRY CALIBRATION VERIFIERS LEVELS A - E FOR BECKMAN COULTER SYNCHRON SYSTEMS

K031921 · Cliniqa Corporation · Chemistry
Aug 2003
Decision
63d
Days
Class 1
Risk

About This 510(k) Submission

K031921 is an FDA 510(k) clearance for the LINICAL CHEMISTRY CALIBRATION VERIFIERS LEVELS A - E FOR BECKMAN COULTER SYNCHRON 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 August 25, 2003, 63 days after receiving the submission on June 23, 2003. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K031921 FDA.gov
FDA Decision Cleared SESE
Date Received June 23, 2003
Decision Date August 25, 2003
Days to Decision 63 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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