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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 NORTH ST.
MEDFIELD,  MA  02052 -1688
Applicant Contact William J Pignato
Correspondent
BAYER CORP.
63 NORTH ST.
MEDFIELD,  MA  02052 -1688
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
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