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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 K924096
Device Name CMV ELISA TEST SYSTEM
Applicant
ZEUS SCIENTIFIC, INC.
P.O. BOX 38
RARITAN,  NJ  08869
Applicant Contact JOSEPH A ROSEBROCK
Correspondent
ZEUS SCIENTIFIC, INC.
P.O. BOX 38
RARITAN,  NJ  08869
Correspondent Contact JOSEPH A ROSEBROCK
Regulation Number866.3175
Classification Product Code
LFZ  
Date Received08/13/1992
Decision Date 04/02/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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