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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antisera, Conjugated Fluorescent, Cytomegalovirus
510(k) Number K893468
Device Name CMV IGG ANTIBODY TEST (INDIRECT FLUORESCENT TEST)
Applicant
Immuno Concepts, Inc.
9779-D Business Park Dr.
Sacramento,  CA  95827
Applicant Contact DON W VALENCIA
Correspondent
Immuno Concepts, Inc.
9779-D Business Park Dr.
Sacramento,  CA  95827
Correspondent Contact DON W VALENCIA
Regulation Number866.3175
Classification Product Code
LIN  
Date Received05/03/1989
Decision Date 07/14/1989
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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