FDA 510(k) Application Details - K112377

Device Classification Name Hexokinase, Glucose

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510(K) Number K112377
Device Name Hexokinase, Glucose
Applicant SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
55 NORTHERN BLVD., SUITE 200
GREAT NECK, NY 11021 US
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Contact SUSAN D GOLDSTEIN-FALK
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Regulation Number 862.1345

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Classification Product Code CFR
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Date Received 08/17/2011
Decision Date 03/23/2012
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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