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FDA 510(k) Application Details - K200277
Device Classification Name
System, Test, Blood Glucose, Over The Counter
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510(K) Number
K200277
Device Name
System, Test, Blood Glucose, Over The Counter
Applicant
Livongo Health, Inc.
150 W. Evelyn Ave, Suite 150
Mountain View, CA 94041 US
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Contact
Jacob Gendler
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Regulation Number
862.1345
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Classification Product Code
NBW
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More FDA Info for this Product Code
Date Received
02/04/2020
Decision Date
06/04/2020
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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