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FDA 510(k) Application Details - K152343
Device Classification Name
Enzymatic Method, Bilirubin
More FDA Info for this Device
510(K) Number
K152343
Device Name
Enzymatic Method, Bilirubin
Applicant
RANDOX LABORATORIES LIMITED
55 DIAMOND ROAD, CRUMLIN
COUNTY ANTRIM BT29 4QY GB
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Contact
PAULINE ARMSTRONG
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Regulation Number
862.1110
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Classification Product Code
JFM
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More FDA Info for this Product Code
Date Received
08/19/2015
Decision Date
02/16/2016
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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