Cleared Traditional

TRIAGE CARDIAC CONTROLS; TRIAGE CARDIO PROFILER CONTROLS

K030089 · Biosite Incorporated · Chemistry
Jan 2003
Decision
13d
Days
Class 1
Risk

About This 510(k) Submission

K030089 is an FDA 510(k) clearance for the TRIAGE CARDIAC CONTROLS; TRIAGE CARDIO PROFILER CONTROLS, a Multi-analyte Controls, All Kinds (assayed) (Class I — General Controls, product code JJY), submitted by Biosite Incorporated (San Diego, US). The FDA issued a Cleared decision on January 23, 2003, 13 days after receiving the submission on January 10, 2003. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K030089 FDA.gov
FDA Decision Cleared SESE
Date Received January 10, 2003
Decision Date January 23, 2003
Days to Decision 13 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

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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