K261364
- 510(k) number
- K261364
- Device name
- Atellica CH Acetaminophen 2 (ACTM)
- Applicant
- Siemens Healthcare Diagnostics, Inc. NY · US
- Product code
- LDP — Colorimetry, Acetaminophen
- Decision date
- 2026-07-24
- Date received
- 2026-04-27
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Toxicology
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K261364.pdf
Official FDA record: K261364
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.