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FDA 510(k) Application Details - K024116
Device Classification Name
Diazo Colorimetry, Bilirubin
More FDA Info for this Device
510(K) Number
K024116
Device Name
Diazo Colorimetry, Bilirubin
Applicant
WIENER LABORATORIES S.A.I.C.
2944 RIOBAMBA
ROSARIO 2000 AR
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Contact
VIVIANA CETILA
Other 510(k) Applications for this Contact
Regulation Number
862.1110
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Classification Product Code
CIG
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/13/2002
Decision Date
02/12/2003
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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