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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lipoprotein, Low-Density, Antigen, Antiserum, Control
510(k) Number K241220
Device Name Tina-quant Lipoprotein(a) Gen.2 Molarity
Applicant
Roche Diagnostics Operations
9115 Hague Rd.
Indianapolos,  IN  46250
Applicant Contact Leslie Patterson
Correspondent
Roche Diagnostics Operations
9115 Hague Rd.
Indianapolos,  IN  46250
Correspondent Contact Leslie Patterson
Regulation Number866.5600
Classification Product Code
DFC  
Date Received05/01/2024
Decision Date 01/24/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
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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