Atellica CH Acetaminophen 2 (ACTM)— 510(k) K261364
Substantially EquivalentSiemens Healthcare Diagnostics, Inc.
FDA 510(k) clearance K261364 for Atellica CH Acetaminophen 2 (ACTM), Substantially Equivalent on 2026-07-24. Applicant: Siemens Healthcare Diagnostics, Inc.. Device class: 2.
Summary
Siemens Healthcare Diagnostics' Atellica CH Acetaminophen 2 (ACTM) is filed under LDP, acetaminophen colorimetry. The record doesn't give the assay's measuring range or sample types.
Class II, 21 CFR 862.3030. The Clinical Chemistry review panel handled it as a Traditional 510(k), though the record lists Clinical Toxicology as the classification panel.
Siemens filed from Tarrytown, New York. Review took 88 calendar days (April 27 to July 24, 2026).
Clearance details
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- Product code
- Product code LDP
- Device class
- Class 2
- Regulation
- 21 CFR 862.3030
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tarrytown, NY, US
Recent devices under product code LDP
view allMore clearances from Siemens Healthcare Diagnostics, Inc.
view allAdverse events under product code LDP
product code LDP- Other
- 1
- Total
- 1
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.