Cleared Traditional

TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST

K021317 · Biosite Incorporated · Chemistry
Jul 2002
Decision
67d
Days
Class 2
Risk

About This 510(k) Submission

K021317 is an FDA 510(k) clearance for the TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST, 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 July 1, 2002, 67 days after receiving the submission on April 25, 2002. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1117.

Submission Details

510(k) Number K021317 FDA.gov
FDA Decision Cleared SESE
Date Received April 25, 2002
Decision Date July 01, 2002
Days to Decision 67 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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