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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
510(k) Number K994221
Device Name BAYER PSA ASSAY
Applicant
Bayer Corp.
63 N. St.
Medfield,  MA  02052
Applicant Contact William J Pignato
Correspondent
Bayer Corp.
63 N. St.
Medfield,  MA  02052
Correspondent Contact William J Pignato
Regulation Number866.6010
Classification Product Code
LTJ  
Date Received12/15/1999
Decision Date 04/13/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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