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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 K903070
Device Name SEROCARD HSV IGG ANTIBODY TEST KIT
Applicant
Disease Detection International, Inc.
#2 Thomas
Irvine,  CA  92718
Applicant Contact JULIE WHITESIDE
Correspondent
Disease Detection International, Inc.
#2 Thomas
Irvine,  CA  92718
Correspondent Contact JULIE WHITESIDE
Regulation Number866.3305
Classification Product Code
LGC  
Date Received07/12/1990
Decision Date 08/09/1990
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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