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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Vancomycin
510(k) Number K222439
Device Name Atellica® CH Phencyclidine (Pcp), Atellica® CH Vancomycin (Vanc)
Applicant
Siemens Healthcare Diagnostics, Inc.
511 Benedict Ave.
New York,  NY  10591
Applicant Contact Joy Anoop
Correspondent
Siemens Healthcare Diagnostics, Inc.
511 Benedict Ave.
New York,  NY  10591
Correspondent Contact Joy Anoop
Regulation Number862.3950
Classification Product Code
LEH  
Subsequent Product Code
LCM  
Date Received08/12/2022
Decision Date 08/08/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
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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