ABBOTT AXSYM B-TYPE NATRIURETIC PEPTIDE (BNP) MICROPARTICLE ENZYME IMMUNOASSAY (MEIA) TEST— 510(k) K033606

Name: FDA 510(k) clearance K033606
Creator: U.S. Food and Drug Administration
Published: 2004-01-30

Substantially Equivalent

Axis-Shield Diagnostics, Ltd.

FDA 510(k) clearance K033606 for ABBOTT AXSYM B-TYPE NATRIURETIC PEPTIDE (BNP) MICROPARTICLE ENZYME IMMUNOASSAY (MEIA) TEST, Substantially Equivalent on 2004-01-30. Applicant: Axis-Shield Diagnostics, Ltd.. Device class: 2.

Clearance details

Applicant: Axis-Shield Diagnostics, Ltd.
Product code: Code NBC
Device class: Class 2
Regulation: 21 CFR 862.1117
Advisory panel: Clinical Chemistry
Date received: 2003-11-17
Decision date: 2004-01-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dundee, Scotland, GB

Download summary PDF View on FDA.gov ↗

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