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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name electrode, ion specific, sodium
510(k) Number K161954
Device Name Atellica Solution, Atellica A-LYTE Integrated Multisensor Na+/K+/CI-, Atellica CH Albumin BCP Reagent (Alb_p), Atellica IM Thyroid Stimulating Hormone TSH, Atellica CH Vancomycin (Vanc)
Applicant
Siemens Healthcare Diagnostics
511 Benedict Avenue
Tarrytown,  NY  10591
Applicant Contact Justin DiValentino
Correspondent
Siemens Healthcare Diagnostics
511 Benedict Avenue
Tarrytown,  NY  10591
Correspondent Contact Justin DiValentino
Regulation Number862.1665
Classification Product Code
JGS  
Subsequent Product Codes
CEM   CGZ   CJW   JJE   JLW  
LEH  
Date Received07/18/2016
Decision Date 03/09/2017
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
Recalls CDRH Recalls
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