Cleared Traditional

CLINIQA LIQUID QC CARDIAC MARKER CONTROL LEVELS 1, 2 & 3, TRI-LEVEL

K030768 · Cliniqa Corporation · Chemistry
Mar 2003
Decision
10d
Days
Class 1
Risk

About This 510(k) Submission

K030768 is an FDA 510(k) clearance for the CLINIQA LIQUID QC CARDIAC MARKER CONTROL LEVELS 1, 2 & 3, TRI-LEVEL, a Enzyme Controls (assayed And Unassayed) (Class I — General Controls, product code JJT), submitted by Cliniqa Corporation (Fallbrook, US). The FDA issued a Cleared decision on March 21, 2003, 10 days after receiving the submission on March 11, 2003. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K030768 FDA.gov
FDA Decision Cleared SESE
Date Received March 11, 2003
Decision Date March 21, 2003
Days to Decision 10 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code JJT — Enzyme Controls (assayed And Unassayed)
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1660

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