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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name hepatitis a test (antibody and igm antibody)
510(k) Number K113704
Device Name ARCHITECT HAVAB-G
Applicant
ABBOTT LABORATORIES
100 ABBOTT PARK RD.
DEPT. 09VA, BLDG. AP5 NORTH
ABBOTT PARK,  IL  60064 -6092
Applicant Contact JUDITH WALLACH
Correspondent
ABBOTT LABORATORIES
100 ABBOTT PARK RD.
DEPT. 09VA, BLDG. AP5 NORTH
ABBOTT PARK,  IL  60064 -6092
Correspondent Contact JUDITH WALLACH
Regulation Number866.3310
Classification Product Code
LOL  
Subsequent Product Codes
JIS   MJX   MJY  
Date Received12/16/2011
Decision Date 06/28/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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