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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Glucose Oxidase, Glucose
510(k) Number K223179
Device Name Cholestech LDX ™ System
Applicant
Alere San Diego, Inc.
9975 Summers Ridge Rd.
San Diego,  CA  92121
Applicant Contact Nathifa Bradshaw
Correspondent
Alere San Diego, Inc.
9942 Mesa Rim Rd.
San Diego,  CA  92121
Correspondent Contact Nathifa Bradshaw
Regulation Number862.1345
Classification Product Code
CGA  
Subsequent Product Codes
CHH   JGY   JJE   LBS  
Date Received10/11/2022
Decision Date 09/20/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Dual Track
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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