Cleared Traditional

MODIFICATION TO TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST

K032235 · Biosite Incorporated · Chemistry
Jan 2004
Decision
191d
Days
Class 2
Risk

About This 510(k) Submission

K032235 is an FDA 510(k) clearance for the MODIFICATION TO 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 January 28, 2004, 191 days after receiving the submission on July 21, 2003. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1117.

Submission Details

510(k) Number K032235 FDA.gov
FDA Decision Cleared SESE
Date Received July 21, 2003
Decision Date January 28, 2004
Days to Decision 191 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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