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FDA 510(k) Application Details - K012326
Device Classification Name
Photometric Method, Magnesium
More FDA Info for this Device
510(K) Number
K012326
Device Name
Photometric Method, Magnesium
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
862.1495
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Classification Product Code
JGJ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/23/2001
Decision Date
11/08/2001
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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