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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Low Density, Lipoprotein
510(k) Number K241800
Device Name Atellica® CH HDL Cholesterol (HDLC)& Atellica® CH LDL Cholesterol (LDLC)
Applicant
Siemens Healthcare Diagnostics, Inc.
500 Gbc Dr.
P.O. Box 6101
Newark,  DE  19711
Applicant Contact Justin Thomas
Correspondent
Siemens Healthcare Diagnostics, Inc.
500 Gbc Dr.
P.O. Box 6101
Newark,  DE  19711
Correspondent Contact Justin Thomas
Regulation Number862.1475
Classification Product Code
MRR  
Subsequent Product Code
LBS  
Date Received06/21/2024
Decision Date 07/26/2024
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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