Cleared Traditional

CLINIQA DRY QC CHEMISTRY CONTROL, LEVELS 1 AND 2, ASSAYED, CLINIQA DRY QC CHEMISTRY CONTROL, LEVEL 1 AND 2 UNASSAYED

K060322 · Cliniqa Corporation · Chemistry
Mar 2006
Decision
40d
Days
Class 2
Risk

About This 510(k) Submission

K060322 is an FDA 510(k) clearance for the CLINIQA DRY QC CHEMISTRY CONTROL, LEVELS 1 AND 2, ASSAYED, CLINIQA DRY QC CHEMISTRY CONTROL, LEVEL 1 AND 2 UNASSAYED, a Calibrator, Secondary (Class II — Special Controls, product code JIT), submitted by Cliniqa Corporation (Fallbrook, US). The FDA issued a Cleared decision on March 21, 2006, 40 days after receiving the submission on February 9, 2006. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1150.

Submission Details

510(k) Number K060322 FDA.gov
FDA Decision Cleared SESE
Date Received February 09, 2006
Decision Date March 21, 2006
Days to Decision 40 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code JIT — Calibrator, Secondary
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1150

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