FDA 510(k) Application Details - K012326

Device Classification Name Photometric Method, Magnesium

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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
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Regulation Number 862.1495

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Classification Product Code JGJ
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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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