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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzymatic Esterase--Oxidase, Cholesterol
510(k) Number K232404
Device Name CHOLESTEROL; HDL-cholesterol ; LDL-cholesterol; TRIGLYCERIDES
Applicant
Medicon Hellas S.A
Melitona 5-7
Gerakas,  GR
Applicant Contact Sotia Mitropoulou
Correspondent
Medicon Hellas S.A
Melitona 5-7
Gerakas,  GR
Correspondent Contact Sotia Mitropoulou
Regulation Number862.1175
Classification Product Code
CHH  
Subsequent Product Codes
CDT   LBS   MRR  
Date Received08/10/2023
Decision Date 08/09/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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