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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 K192790
Device Name Atellica IM Total hCG (ThCG)
Applicant
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave.
tarrytown,  NY  10591
Applicant Contact mey lyn vasquez
Correspondent
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave.
tarrytown,  NY  10591
Correspondent Contact mey lyn vasquez
Regulation Number862.1155
Classification Product Code
DHA  
Date Received09/30/2019
Decision Date 10/30/2019
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
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