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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antibody Igm,If, Cytomegalovirus Virus
510(k) Number K933549
Device Name VIDAS CMV IGM ASSAY
Applicant
BIOMERIEUX VITEK, INC.
1022 HINGHAM ST.
ROCKLAND,  MA  02370
Applicant Contact VICKI ANASTASI
Correspondent
BIOMERIEUX VITEK, INC.
1022 HINGHAM ST.
ROCKLAND,  MA  02370
Correspondent Contact VICKI ANASTASI
Regulation Number866.3175
Classification Product Code
LKQ  
Date Received07/22/1993
Decision Date 08/02/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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