LDP

Colorimetry, Acetaminophen

Product code
LDP
Device name
Colorimetry, Acetaminophen
Device class
Class 2
21 CFR
21 CFR 862.3030
Medical specialty
Clinical Toxicology
Marketing pathway
510(K)
Flag
Third-party review eligible
510(k) clearances (last 3 years)
37

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2026-07-24.

NumberDecision dateApplicantDevice nameSummary
K2613642026-07-24Siemens Healthcare Diagnostics, Inc.Atellica CH Acetaminophen 2 (ACTM)PDF

1 summaries are archived here for direct download.

Official FDA classification page: LDP
Classification and pathway per current FDA publications. Data from openFDA (CC0).