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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 K002121
Device Name TOTAL PSA MICROTITER ELISA
Applicant
Oncogene Science, Inc.
80 Rogers St.
Cambridge,  MA  02142
Applicant Contact SHERYL BROWN-SHIMER
Correspondent
Oncogene Science, Inc.
80 Rogers St.
Cambridge,  MA  02142
Correspondent Contact SHERYL BROWN-SHIMER
Regulation Number866.6010
Classification Product Code
LTJ  
Date Received07/13/2000
Decision Date 08/30/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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