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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test, Natriuretic Peptide
510(k) Number K033606
Device Name ABBOTT AXSYM B-TYPE NATRIURETIC PEPTIDE (BNP) MICROPARTICLE ENZYME IMMUNOASSAY (MEIA) TEST
Applicant
Axis-Shield Diagnostics, Ltd.
The Technology Park
Luna Pl.
Dundee, Scotland,  GB DD2 1XA
Applicant Contact JUDITH FINLAYSON, PH.D.
Correspondent
Axis-Shield Diagnostics, Ltd.
The Technology Park
Luna Pl.
Dundee, Scotland,  GB DD2 1XA
Correspondent Contact JUDITH FINLAYSON, PH.D.
Regulation Number862.1117
Classification Product Code
NBC  
Subsequent Product Codes
JIT   JJX  
Date Received11/17/2003
Decision Date 01/30/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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