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510(k) K183678

i-STAT CHEM8+ cartridge with the i-STAT 1 System by Abbott Point of Care, Inc. — Product Code CGA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 7, 2020
Date Received
December 28, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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