FDA 510(k) Application Details - K000926

Device Classification Name Electrode, Ion-Specific, Chloride

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510(K) Number K000926
Device Name Electrode, Ion-Specific, Chloride
Applicant MEDICA CORP.
14 DEANGELO DR.
BEDFORD, MA 01730 US
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Contact Photios Makris
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Regulation Number 862.1170

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Classification Product Code CGZ
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Date Received 03/22/2000
Decision Date 05/15/2000
Decision SESE - SUBST EQUIV
Classification Advisory Committee CH - Clinical Chemistry
Review Advisory Committee CH - Clinical Chemistry
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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