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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 K904456
Device Name CYTOMEGALOVIRUS (CMV) ELISA
Applicant
Virotech, Inc.
C/O Schiff & Co.
583 Mountain Ave.
North Caldwell,  NJ  07006
Applicant Contact ROBERT SCHIFF
Correspondent
Virotech, Inc.
C/O Schiff & Co.
583 Mountain Ave.
North Caldwell,  NJ  07006
Correspondent Contact ROBERT SCHIFF
Regulation Number866.3175
Classification Product Code
LFZ  
Date Received10/01/1990
Decision Date 04/03/1991
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
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