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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Diazo Colorimetry, Bilirubin
510(k) Number K251998
Device Name Atellica CH Diazo Total Bilirubin (D_TBil)
Applicant
Siemens Healthcare Diagnostics, Inc.
500 Gbc Dr.
Newark,  DE  19714
Applicant Contact Anthony Calabro
Correspondent
Siemens Healthcare Diagnostics, Inc.
500 Gbc Dr.
Newark,  DE  19714
Correspondent Contact Anthony Calabro
Regulation Number862.1110
Classification Product Code
CIG  
Subsequent Product Code
MQM  
Date Received06/27/2025
Decision Date 02/27/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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