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FDA 510(k) Application Details - K120989
Device Classification Name
System, Test, Blood Glucose, Over The Counter
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510(K) Number
K120989
Device Name
System, Test, Blood Glucose, Over The Counter
Applicant
NIPRO DIAGNOSTICS, INC.
2200 W Cypress Creek Rd
Fort Lauderdale, FL 33309 US
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KAREN DEVINCENT
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Regulation Number
862.1345
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Classification Product Code
NBW
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Date Received
04/02/2012
Decision Date
04/24/2013
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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