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FDA 510(k) Application Details - K012260
Device Classification Name
Urease And Glutamic Dehydrogenase, Urea Nitrogen
More FDA Info for this Device
510(K) Number
K012260
Device Name
Urease And Glutamic Dehydrogenase, Urea Nitrogen
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
862.1770
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Classification Product Code
CDQ
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More FDA Info for this Product Code
Date Received
07/18/2001
Decision Date
09/19/2001
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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