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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name radioassay, intrinsic factor blocking antibody
510(k) Number K984108
Device Name ABBOTT ARCHITECT B12
Applicant
ABBOTT LABORATORIES
200 ABBOTT PARK RD.
ABBOTT PARK,  IL  60064
Applicant Contact LAURA L GRANITZ
Correspondent
ABBOTT LABORATORIES
200 ABBOTT PARK RD.
ABBOTT PARK,  IL  60064
Correspondent Contact LAURA L GRANITZ
Regulation Number862.1810
Classification Product Code
LIG  
Date Received11/17/1998
Decision Date 02/03/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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