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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 K902662
Device Name BARTELS HERPES SIMPLEX VIR FLU MONO ANTIBODY TEST
Applicant
Baxter Healthcare Corp
P.O. Box 3093
Bellevue,  WA  98009
Applicant Contact LORRAINE W HUFFMAN
Correspondent
Baxter Healthcare Corp
P.O. Box 3093
Bellevue,  WA  98009
Correspondent Contact LORRAINE W HUFFMAN
Regulation Number866.3305
Classification Product Code
GQL  
Date Received06/18/1990
Decision Date 07/31/1990
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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