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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, Herpes Simplex Virus, Non-Specific
510(k) Number K915551
Device Name ORTHO HSV ANTIGEN 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 Number866.3305
Classification Product Code
LGC  
Date Received12/11/1991
Decision Date 04/22/1992
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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