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FDA 510(k) Application Details - K002313
Device Classification Name
Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
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510(K) Number
K002313
Device Name
Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
Applicant
ONCOGENE SCIENCE, INC.
80 ROGERS ST.
CAMBRIDGE, MA 02142 US
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Contact
SHERYL BROWN-SHIMER
Other 510(k) Applications for this Contact
Regulation Number
866.6010
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Classification Product Code
LTJ
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More FDA Info for this Product Code
Date Received
07/31/2000
Decision Date
08/30/2000
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
IM - Immunology
Review Advisory Committee
IM - Immunology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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