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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name radioassay, vitamin b12
510(k) Number K051327
Device Name ABBOTT AXSYM B12
Applicant
ABBOTT LABORATORIES
100 ABBOTT PARK RD.
ABBOTT PARK,  IL  60064 -6095
Applicant Contact MARGARET PROCHNIAK
Correspondent
ABBOTT LABORATORIES
100 ABBOTT PARK RD.
ABBOTT PARK,  IL  60064 -6095
Correspondent Contact MARGARET PROCHNIAK
Regulation Number862.1810
Classification Product Code
CDD  
Date Received05/20/2005
Decision Date 08/03/2005
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
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