Cleared Traditional

CLINIQA LIQUIDQC IMMUNOASSAY CONTROL LEVEL 1, 2 & 3

K083554 · Cliniqa Corporation · Chemistry
Apr 2009
Decision
141d
Days
Class 1
Risk

About This 510(k) Submission

K083554 is an FDA 510(k) clearance for the CLINIQA LIQUIDQC IMMUNOASSAY CONTROL LEVEL 1, 2 & 3, 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 April 21, 2009, 141 days after receiving the submission on December 1, 2008. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K083554 FDA.gov
FDA Decision Cleared SESE
Date Received December 01, 2008
Decision Date April 21, 2009
Days to Decision 141 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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