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FDA 510(k) Application Details - K083223
Device Classification Name
Glucose Dehydrogenase, Glucose
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510(K) Number
K083223
Device Name
Glucose Dehydrogenase, Glucose
Applicant
ABBOTT DIABETES CARE INC.
1360 SOUTH LOOP RD.
ALAMEDA, CA 94502 US
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Contact
ARUL STERLIN
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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
11/03/2008
Decision Date
04/16/2009
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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