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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Colorimetry, Acetaminophen
510(k) Number K261364
Device Name Atellica CH Acetaminophen 2 (ACTM)
Applicant
Siemens Healthcare Diagnostics, Inc.
511 Benedict Ave.
Tarrytown,  NY  10591
Applicant Contact Kelly Maher
Correspondent
Siemens Healthcare Diagnostics, Inc.
511 Benedict Ave.
Tarrytown,  NY  10591
Correspondent Contact Kelly Maher
Regulation Number862.3030
Classification Product Code
LDP  
Date Received04/27/2026
Decision Date 07/24/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
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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