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FDA 510(k) Application Details - K021332
Device Classification Name
Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
More FDA Info for this Device
510(K) Number
K021332
Device Name
Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
Applicant
WIENER LABORATORIES S.A.I.C.
2944 RIOBAMBA
ROSARIO 2000 AR
Other 510(k) Applications for this Company
Contact
VIVIANA CETOLA
Other 510(k) Applications for this Contact
Regulation Number
862.1215
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Classification Product Code
CGS
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/26/2002
Decision Date
07/03/2002
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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