Cleared Traditional

LINICAL PROTEIN 2 CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER ARRAY PROTEIN SYSTEMS

K031577 · Cliniqa Corporation · Chemistry
Aug 2003
Decision
78d
Days
Class 1
Risk

About This 510(k) Submission

K031577 is an FDA 510(k) clearance for the LINICAL PROTEIN 2 CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER ARRAY PROTEIN 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 6, 2003, 78 days after receiving the submission on May 20, 2003. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K031577 FDA.gov
FDA Decision Cleared SESE
Date Received May 20, 2003
Decision Date August 06, 2003
Days to Decision 78 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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