Cleared Traditional

TRIAGE CARDIAC CALIBRATION VERIFICATION CONTROLS, TRIAGE CARDIO PROFILER CALIBRATION VERFICICATION CONTROLS

K030088 · Biosite Incorporated · Chemistry
Jan 2003
Decision
7d
Days
Class 1
Risk

About This 510(k) Submission

K030088 is an FDA 510(k) clearance for the TRIAGE CARDIAC CALIBRATION VERIFICATION CONTROLS, TRIAGE CARDIO PROFILER CALIBRATION VERFICICATION 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 17, 2003, 7 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 K030088 FDA.gov
FDA Decision Cleared SESE
Date Received January 10, 2003
Decision Date January 17, 2003
Days to Decision 7 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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