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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Parathyroid Hormone
510(k) Number K231927
Device Name Elecsys PTH , Elecsys PTH STAT
Applicant
Roche Diagnostics
9115 Hague Rd.
Bldg. B
Indianapolis,  IN  46250
Applicant Contact Amy Pierce
Correspondent
Roche Diagnostics
9115 Hague Rd.
Bldg. B
Indianapolis,  IN  46250
Correspondent Contact Amy Pierce
Regulation Number862.1545
Classification Product Code
CEW  
Date Received06/30/2023
Decision Date 03/22/2024
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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