Cleared Traditional

TRIAGE CARDIOPROFILER AND PROFILER S.O.B. PANELS

K080269 · Biosite Incorporated · Chemistry
Jun 2008
Decision
126d
Days
Class 2
Risk

About This 510(k) Submission

K080269 is an FDA 510(k) clearance for the TRIAGE CARDIOPROFILER AND PROFILER S.O.B. PANELS, a Test, Natriuretic Peptide (Class II — Special Controls, product code NBC), submitted by Biosite Incorporated (San Deigo, US). The FDA issued a Cleared decision on June 6, 2008, 126 days after receiving the submission on February 1, 2008. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1117.

Submission Details

510(k) Number K080269 FDA.gov
FDA Decision Cleared SESE
Date Received February 01, 2008
Decision Date June 06, 2008
Days to Decision 126 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code NBC — Test, Natriuretic Peptide
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1117

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