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FDA 510(k) Application Details - K210958
Device Classification Name
Glucose Oxidase, Glucose
More FDA Info for this Device
510(K) Number
K210958
Device Name
Glucose Oxidase, Glucose
Applicant
Abbott Point of Care Inc.
400 College Road East
Princeton, NJ 08540 US
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Contact
Maria Figueroa
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Regulation Number
862.1345
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Classification Product Code
CGA
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More FDA Info for this Product Code
Date Received
03/31/2021
Decision Date
08/13/2021
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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