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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antigens, Cf (Including Cf Control), Parainfluenza Virus 1-4
510(k) Number K871234
Device Name ANTIBODY ASSAY FOR DETECT. OF PARAINFLUENZA TYPE 1
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 Number866.3400
Classification Product Code
GQS  
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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