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FDA 510(k) Application Details - K013983
Device Classification Name
Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
More FDA Info for this Device
510(K) Number
K013983
Device Name
Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
Applicant
WIENER LABORATORIES S.A.I.C.
2944 RIOBAMBA
ROSARIO 2000 AR
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Contact
VIVIANA CETOLA
Other 510(k) Applications for this Contact
Regulation Number
862.1050
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Classification Product Code
CJE
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More FDA Info for this Product Code
Date Received
12/03/2001
Decision Date
01/28/2002
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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