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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Respiratory Syncytial Virus, Antigen, Antibody, Ifa
510(k) Number K871230
Device Name ANTIBODY ASSAY FOR DETEC. OF RESP. SYNCYTIAL VIRUS
Applicant
Microscan Div. Baxter Healthcare Corp.
2040 Enterprise Blvd.
West Sacramento,  CA  95691
Applicant Contact HOWARD G TAYLOR
Correspondent
Microscan Div. Baxter Healthcare Corp.
2040 Enterprise Blvd.
West Sacramento,  CA  95691
Correspondent Contact HOWARD G TAYLOR
Regulation Number866.3480
Classification Product Code
LKT  
Date Received03/27/1987
Decision Date 06/26/1987
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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