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510(k) K223179

Cholestech LDX ™ System by Alere San Diego, Inc. — Product Code CGA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 20, 2023
Date Received
October 11, 2022
Clearance Type
Dual Track
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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