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FDA 510(k) Application Details - K012065
Device Classification Name
Enzymatic Method, Creatinine
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510(K) Number
K012065
Device Name
Enzymatic Method, Creatinine
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
862.1225
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Classification Product Code
JFY
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More FDA Info for this Product Code
Date Received
07/02/2001
Decision Date
10/10/2001
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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