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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antisera, Fluorescent, Herpesvirus Hominis 1,2
510(k) Number K870814
Device Name HERPES SIMPLEX ANTIBODY TEST FOR DECT. OF HSV 1&2
Applicant
Microscan Div. Baxter Healthcare Corp.
2040 Enterprise Blvd.
West Sacramento,  CA  95691
Applicant Contact LORRAINE WEAVER
Correspondent
Microscan Div. Baxter Healthcare Corp.
2040 Enterprise Blvd.
West Sacramento,  CA  95691
Correspondent Contact LORRAINE WEAVER
Regulation Number866.3305
Classification Product Code
GQL  
Date Received03/03/1987
Decision Date 06/04/1987
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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