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FDA 510(k) Application Details - K973101
Device Classification Name
Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
More FDA Info for this Device
510(K) Number
K973101
Device Name
Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
Applicant
DADE CHEMISTRY SYSTEMS, INC.
GLASGOW SITE
P.O. BOX 6101
NEWARK, DE 19714-6101 US
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Contact
REBECCA S AYASH
Other 510(k) Applications for this Contact
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
08/19/1997
Decision Date
09/18/1997
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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