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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antisera, Cf, Influenza Virus A, B, C
510(k) Number K896635
Device Name VIRAL RESPIRATORY INDIRECT FLUORES. MONO. ANTIBODY
Applicant
Baxter Healthcare Corp
P.O. Box 3093
Bellevue,  WA  98009
Applicant Contact HOWARD TAYLOR
Correspondent
Baxter Healthcare Corp
P.O. Box 3093
Bellevue,  WA  98009
Correspondent Contact HOWARD TAYLOR
Regulation Number866.3330
Classification Product Code
GNW  
Date Received11/22/1989
Decision Date 02/02/1990
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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