Atellica CH Acetaminophen 2 (ACTM)
FDA 510(k) K261364 · Siemens Healthcare Diagnostics, Inc.
510(k) numberK261364
Submission
- Device name
- Atellica CH Acetaminophen 2 (ACTM)
- Applicant
- Siemens Healthcare Diagnostics, Inc.
Tarrytown, NY, US - Received
- April 27, 2026
- Decision date
- July 24, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LDP – Colorimetry, Acetaminophen
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3030
- Specialty
- Clinical Toxicology
Other 510(k)s with product code LDP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K202644 | AcetaminophenLDP · Traditional | Sekisui Diagnostics P.E.I., Inc. | 02/18/2022SE |
| K180835 | SEKURE Acetaminophen L3K AssayLDP · Traditional | Sekisui Diagnostics P.E.I., Inc. | 02/08/2019SE |
| K110726 | Roche Acetaminophen AssayLDP · Traditional | Roche Diagnostics | 12/23/2011SE |
| K100200 | Advia Chemistry Acetaminophen Reagent, Model Ref 07989138LDP · Traditional | Siemens Healthcare Diagnostics | 08/02/2010SE |
| K081938 | Acetaminophen L3K Assay, and Acetaminophen L3K Assay, Models 506-10, 506-30LDP · Traditional | Genzyme Diagnostics P.E.I., Inc. | 05/01/2009SE |
| K061655 | Dimension Vista Flex Reagent CartridgesLDP · Special | Dade Behring, Inc. | 07/10/2006SE |
| K043242 | Triage Tox Drug ScreenLDP · Traditional | Biosite Incorporated | 02/28/2005SE |
| K042330 | Acetaminophen-Sl AssayLDP · Traditional | Diagnostic Chemicals , Ltd. | 01/07/2005SE |
| K020792 | Acetaminophen Assay for the Advia Integrated Modular SystemLDP · Traditional | Bayer Diagnostics Corp. | 07/11/2002SE |
| K013757 | Roche AcetaminophenLDP · Traditional | Roche Diagnostics Corp. | 01/08/2002SE |
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| 510(k) | Device | Decision |
|---|---|---|
| K253528 | Atellica IM CA 19-9 IINIG · Traditional | 08/10/2026SE |
| K251998 | Atellica CH Diazo Total Bilirubin (D_TBil)CIG · Traditional | 02/27/2026SE |
| K251543 | Atellica® IM TSH3-Ultra II (TSH3ULII)JLW · Traditional | 02/06/2026SE |
| K251630 | Atellica IM Total PSA II (tPSAII)LTJ · Traditional | 01/05/2026SE |
| K250816 | ADVIA Centaur Anti-Thyroglobulin II (aTgII)JNL · Traditional | 12/04/2025SE |
| K250250 | ADVIA Centaur Anti-Thyroid Peroxidase IIJZO · Traditional | 10/17/2025SE |
| K242981 | Atellica IM Thyroglobulin (Tg)MSW · Traditional | 06/20/2025SE |
| K243570 | Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL); Dimension LOCI…JLW · Traditional | 04/25/2025SE |
| K242685 | Atellica® CH Creatinine_3 (Crea3)CGX · Traditional | 12/04/2024SE |
| K241800 | Atellica® CH HDL Cholesterol (HDLC)& Atellica® CH LDL Cholesterol (LDLC)MRR · Traditional | 07/26/2024SE |
Questions and answers
When was Atellica CH Acetaminophen 2 (ACTM) cleared by the FDA?
Atellica CH Acetaminophen 2 (ACTM) (K261364) received a 510(k) decision of Substantially Equivalent on July 24, 2026, 88 days after the submission was received.
What is the product code of K261364?
The FDA product code is LDP – Colorimetry, Acetaminophen, a Class II (moderate risk) device regulated under 21 CFR 862.3030.