Cleared Traditional

TRIAGE BNP TEST, MODEL 98000XR

K051787 · Biosite Incorporated · Chemistry
Sep 2005
Decision
83d
Days
Class 2
Risk

About This 510(k) Submission

K051787 is an FDA 510(k) clearance for the TRIAGE BNP TEST, MODEL 98000XR, 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 September 22, 2005, 83 days after receiving the submission on July 1, 2005. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1117.

Submission Details

510(k) Number K051787 FDA.gov
FDA Decision Cleared SESE
Date Received July 01, 2005
Decision Date September 22, 2005
Days to Decision 83 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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