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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Anti-Müllerian Hormone Test System
510(k) Number K203757
Device Name Elecsys AMH
Applicant
Roche Diagnostics
9115 Hague Rd.
Indianapolos,  IN  46250
Applicant Contact Edie Eads
Correspondent
Roche Diagnostics
9115 Hague Rd.
Indianapolos,  IN  46250
Correspondent Contact Edie Eads
Classification Product Code
PQO  
Date Received12/23/2020
Decision Date 06/10/2022
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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