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FDA 510(k) Application Details - K974842
Device Classification Name
Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
More FDA Info for this Device
510(K) Number
K974842
Device Name
Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
Applicant
DIAGNOSTIC PRODUCTS CORP.
5700 WEST 96TH ST.
LOS ANGELES, CA 90045-5597 US
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Contact
ROBERT M DI TULLIO
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Regulation Number
866.6010
More FDA Info for this Regulation Number
Classification Product Code
LTJ
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More FDA Info for this Product Code
Date Received
12/24/1997
Decision Date
04/21/1998
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
IM - Immunology
Review Advisory Committee
IM - Immunology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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