Cleared Traditional

TRIAGE BNP TEST FOR BECKMAN COULTER IMMUNOASSAY SYSTEMS, MODEL 98200

K052789 · Biosite Incorporated · Chemistry
Jan 2006
Decision
112d
Days
Class 2
Risk

About This 510(k) Submission

K052789 is an FDA 510(k) clearance for the TRIAGE BNP TEST FOR BECKMAN COULTER IMMUNOASSAY SYSTEMS, MODEL 98200, 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 January 23, 2006, 112 days after receiving the submission on October 3, 2005. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1117.

Submission Details

510(k) Number K052789 FDA.gov
FDA Decision Cleared SESE
Date Received October 03, 2005
Decision Date January 23, 2006
Days to Decision 112 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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