Cleared Traditional

ABBOTT AXSYM B-TYPE NATRIURETIC PEPTIDE (BNP) MICROPARTICLE ENZYME IMMUNOASSAY (MEIA) TEST

K033606 · Axis-Shield Diagnostics, Ltd. · Chemistry
Jan 2004
Decision
74d
Days
Class 2
Risk

About This 510(k) Submission

K033606 is an FDA 510(k) clearance for the ABBOTT AXSYM B-TYPE NATRIURETIC PEPTIDE (BNP) MICROPARTICLE ENZYME IMMUNOASSAY (MEIA) TEST, a Test, Natriuretic Peptide (Class II — Special Controls, product code NBC), submitted by Axis-Shield Diagnostics, Ltd. (Dundee, Scotland, GB). The FDA issued a Cleared decision on January 30, 2004, 74 days after receiving the submission on November 17, 2003. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1117.

Submission Details

510(k) Number K033606 FDA.gov
FDA Decision Cleared SESE
Date Received November 17, 2003
Decision Date January 30, 2004
Days to Decision 74 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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