Cleared Traditional

TRIAGE PROFILER S.O.B. CONTROLS AND S.O.B. CALIBRATION VERIFICATION CONTROLS

K040459 · Biosite Incorporated · Chemistry
Jul 2004
Decision
134d
Days
Class 1
Risk

About This 510(k) Submission

K040459 is an FDA 510(k) clearance for the TRIAGE PROFILER S.O.B. CONTROLS AND S.O.B. CALIBRATION VERIFICATION 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 July 6, 2004, 134 days after receiving the submission on February 23, 2004. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K040459 FDA.gov
FDA Decision Cleared SESE
Date Received February 23, 2004
Decision Date July 06, 2004
Days to Decision 134 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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