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FDA 510(k) Application Details - K153692
Device Classification Name
Glucose Oxidase, Glucose
More FDA Info for this Device
510(K) Number
K153692
Device Name
Glucose Oxidase, Glucose
Applicant
INFRARED LABORATORY SYSTEMS, LLC (DBA SYNERMED)
17408 TILLER COURT SUITE 1900
WESTFIELD, IN 40674 US
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Contact
JULIE PASCHAL
Other 510(k) Applications for this Contact
Regulation Number
862.1345
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Classification Product Code
CGA
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More FDA Info for this Product Code
Date Received
12/23/2015
Decision Date
06/24/2016
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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