Cleared Traditional

TRIAGE BNP TEST FOR THE BECKMAN COULTER IMMUNOASSAY SYSTEMS, MODEL CATALOG #98200

K033383 · Biosite Incorporated · Chemistry
Dec 2003
Decision
61d
Days
Class 2
Risk

About This 510(k) Submission

K033383 is an FDA 510(k) clearance for the TRIAGE BNP TEST FOR THE BECKMAN COULTER IMMUNOASSAY SYSTEMS, MODEL CATALOG #98200, 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 December 23, 2003, 61 days after receiving the submission on October 23, 2003. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1117.

Submission Details

510(k) Number K033383 FDA.gov
FDA Decision Cleared SESE
Date Received October 23, 2003
Decision Date December 23, 2003
Days to Decision 61 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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