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FDA 510(k) Application Details - K142595
Device Classification Name
More FDA Info for this Device
510(K) Number
K142595
Device Name
VITROS Chemistry Products HbA 1c Reagent Kit, VITROS Calibrator Kit 31, VITROS Chemistry Products %A1c Performance Verifiers I and II
Applicant
ORTHO CLINICAL DIAGNOSTICS
100 INDIGO CREEK DRIVE
ROCHESTER, NY 14626 US
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Contact
Bradley P Boyer
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Regulation Number
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Classification Product Code
PDJ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/15/2014
Decision Date
06/04/2015
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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