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FDA 510(k) Application Details - K223537
Device Classification Name
More FDA Info for this Device
510(K) Number
K223537
Device Name
FreeStyle Libre 2 System, FreeStyle Libre 3 System
Applicant
Abbott Diabetes Care Inc.
1360 South Loop Road
Alameda, CA 94502 US
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Contact
Simon Yuan
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Regulation Number
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Classification Product Code
QLG
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Date Received
11/23/2022
Decision Date
02/21/2023
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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