FDA 510(k) Application Details - K092737

Device Classification Name Photometric Method, Magnesium

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510(K) Number K092737
Device Name Photometric Method, Magnesium
Applicant MEDICA CORP.
5 OAK PARK DRIVE
BEDFORD, MA 01730 US
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Contact Photios Makris
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Regulation Number 862.1495

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Classification Product Code JGJ
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Date Received 09/08/2009
Decision Date 11/17/2009
Decision SESE - SUBST EQUIV
Classification Advisory Committee CH - Clinical Chemistry
Review Advisory Committee CH - Clinical Chemistry
Statement / Summary / Purged Status Statement
Type Special
Reviewed By Third Party N
Expedited Review



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