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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, Human Chorionic Gonadotropin
510(k) Number K203227
Device Name Elecsys HCG STAT
Applicant
Roche Diagnostics
9115 Hague Rd.
P.O. Box 50416
Indianpolis,  IN  46250
Applicant Contact Adennis N. Cora
Correspondent
Roche Diagnostics
9115 Hague Rd.
P.O. Box 50416
Indianpolis,  IN  46250
Correspondent Contact Adennis N. Cora
Regulation Number862.1155
Classification Product Code
DHA  
Date Received11/02/2020
Decision Date 08/18/2021
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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