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FDA 510(k) Application Details - K122338
Device Classification Name
System, Test, Blood Glucose, Over The Counter
More FDA Info for this Device
510(K) Number
K122338
Device Name
System, Test, Blood Glucose, Over The Counter
Applicant
PRODIGY DIABETES CARE, LLC
1468 Harwell Avenue
Crofton, MD 21114 US
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Contact
E.J. Smith
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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
08/02/2012
Decision Date
11/05/2013
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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