Cleared Traditional

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

K040535 · Cliniqa Corporation · Chemistry
Mar 2004
Decision
27d
Days
Class 1
Risk

About This 510(k) Submission

K040535 is an FDA 510(k) clearance for the LINICAL ENZYME 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 March 29, 2004, 27 days after receiving the submission on March 2, 2004. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K040535 FDA.gov
FDA Decision Cleared SESE
Date Received March 02, 2004
Decision Date March 29, 2004
Days to Decision 27 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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