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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name enzyme linked immunoabsorbent assay, cytomegalovirus
510(k) Number K954301
Device Name ABBOTT CMV TOTAL ANTIBODY EIA (MODIFICATION)
Applicant
ABBOTT LABORATORIES
100 ABBOTT PARK RD. D49C
ABBOTT PARK,  IL  60064 -3500
Applicant Contact MARY SPIEWAK
Correspondent
ABBOTT LABORATORIES
100 ABBOTT PARK RD. D49C
ABBOTT PARK,  IL  60064 -3500
Correspondent Contact MARY SPIEWAK
Regulation Number866.3175
Classification Product Code
LFZ  
Date Received08/23/1995
Decision Date 03/24/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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