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510(k) K170316

ALINITY C GLUCOSE REAGENT KIT, ALINITY C SYSTEM by Abbott Laboratories — Product Code CFR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 19, 2017
Date Received
February 1, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hexokinase, Glucose
Device Class
Class II
Regulation Number
862.1345
Review Panel
CH
Submission Type

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