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FDA 510(k) Application Details - K193371
Device Classification Name
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510(K) Number
K193371
Device Name
FreeStyle Libre 2 Flash Glucose Monitoring System
Applicant
Abbott Diabetes Care Inc.
1360 South Loop Road
Alameda, CA 94502 US
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Contact
Naveen Thuramalla
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Regulation Number
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Classification Product Code
QLG
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Date Received
12/05/2019
Decision Date
06/12/2020
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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