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FDA 510(k) Application Details - K111874
Device Classification Name
Glucose Dehydrogenase, Glucose
More FDA Info for this Device
510(K) Number
K111874
Device Name
Glucose Dehydrogenase, Glucose
Applicant
ABBOTT LABORATORIES
1360 SOUTH LOOP ROAD
ALAMEDA, CA 94502 US
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Contact
ARUL STERLIN
Other 510(k) Applications for this Contact
Regulation Number
862.1345
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Classification Product Code
LFR
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More FDA Info for this Product Code
Date Received
07/01/2011
Decision Date
02/16/2012
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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