Cleared Traditional

CLINIQA LIQUID QC URINE CHEMISTRY CONTROLS, LEVELS 1 AND 2

K082107 · Cliniqa Corporation · Chemistry
Sep 2008
Decision
54d
Days
Class 1
Risk

About This 510(k) Submission

K082107 is an FDA 510(k) clearance for the CLINIQA LIQUID QC URINE CHEMISTRY CONTROLS, LEVELS 1 AND 2, a Multi-analyte Controls, All Kinds (assayed) (Class I — General Controls, product code JJY), submitted by Cliniqa Corporation (San Marcos, US). The FDA issued a Cleared decision on September 17, 2008, 54 days after receiving the submission on July 25, 2008. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K082107 FDA.gov
FDA Decision Cleared SESE
Date Received July 25, 2008
Decision Date September 17, 2008
Days to Decision 54 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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