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FDA 510(k) Application Details - K140690
Device Classification Name
Urease And Glutamic Dehydrogenase, Urea Nitrogen
More FDA Info for this Device
510(K) Number
K140690
Device Name
Urease And Glutamic Dehydrogenase, Urea Nitrogen
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
Other 510(k) Applications for this Contact
Regulation Number
862.1770
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Classification Product Code
CDQ
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More FDA Info for this Product Code
Date Received
03/19/2014
Decision Date
09/02/2014
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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