Cleared Traditional

TRIAGE TOTAL CONTROLS 5, TRIAGE TOTAL CALIBRATION VERIFICATION 5

K072892 · Biosite Incorporated · Chemistry
Dec 2007
Decision
58d
Days
Class 1
Risk

About This 510(k) Submission

K072892 is an FDA 510(k) clearance for the TRIAGE TOTAL CONTROLS 5, TRIAGE TOTAL CALIBRATION VERIFICATION 5, a Multi-analyte Controls, All Kinds (assayed) (Class I — General Controls, product code JJY), submitted by Biosite Incorporated (San Deigo, US). The FDA issued a Cleared decision on December 7, 2007, 58 days after receiving the submission on October 10, 2007. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K072892 FDA.gov
FDA Decision Cleared SESE
Date Received October 10, 2007
Decision Date December 07, 2007
Days to Decision 58 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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