FDA 510(k) Application Details - K162020

Device Classification Name Electrode, Ion-Specific, Chloride

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510(K) Number K162020
Device Name Electrode, Ion-Specific, Chloride
Applicant Ortho Clinical Diagnostics
100 Indigo Creek Drive
Rochester, NY 14626 US
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Contact Marlene Hanna
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Regulation Number 862.1170

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Classification Product Code CGZ
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Date Received 07/21/2016
Decision Date 12/16/2016
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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