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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 K905078
Device Name ORTHO CMV-G ANTIBODY ELISA TEST
Applicant
Ortho Diagnostic Systems, Inc.
1125 Mark Ave.
Carpinteria,  CA  93013
Applicant Contact KIM W GRAY
Correspondent
Ortho Diagnostic Systems, Inc.
1125 Mark Ave.
Carpinteria,  CA  93013
Correspondent Contact KIM W GRAY
Regulation Number866.3175
Classification Product Code
LFZ  
Date Received11/13/1990
Decision Date 12/17/1990
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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