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FDA 510(k) Application Details - K974816
Device Classification Name
Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
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510(K) Number
K974816
Device Name
Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
Applicant
BECKMAN INSTRUMENTS, INC.
1000 LAKE HAZELTINE DR.
CHASKA, MN 55318-1084 US
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Contact
ELLEN VOSS
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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
12/23/1997
Decision Date
02/20/1998
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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