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FDA 510(k) Application Details - K030482
Device Classification Name
Multi-Analyte Controls, All Kinds (Assayed)
More FDA Info for this Device
510(K) Number
K030482
Device Name
Multi-Analyte Controls, All Kinds (Assayed)
Applicant
WIENER LABORATORIES
2944 RIOBAMBA
ROSARIO 2000 AR
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Contact
VIVIANA CETOLA
Other 510(k) Applications for this Contact
Regulation Number
862.1660
More FDA Info for this Regulation Number
Classification Product Code
JJY
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/13/2003
Decision Date
03/19/2003
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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