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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
Original Applicant
ABBOTT LABORATORIES
100 abbott park rd.
dept. 09va, bldg. ap5 north
abbott park,  IL  60064 -6092
Original 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
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