Cleared Special

TRIAGE CARDIO PROFILER/TRIAGE CARDIAC PANEL

K030286 · Biosite Incorporated · Chemistry
Feb 2003
Decision
24d
Days
Class 2
Risk

About This 510(k) Submission

K030286 is an FDA 510(k) clearance for the TRIAGE CARDIO PROFILER/TRIAGE CARDIAC PANEL, a Test, Natriuretic Peptide (Class II — Special Controls, product code NBC), submitted by Biosite Incorporated (San Diego, US). The FDA issued a Cleared decision on February 21, 2003, 24 days after receiving the submission on January 28, 2003. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1117.

Submission Details

510(k) Number K030286 FDA.gov
FDA Decision Cleared SESE
Date Received January 28, 2003
Decision Date February 21, 2003
Days to Decision 24 days
Submission Type Special
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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