Acetaminophen
FDA 510(k) K202644 · Sekisui Diagnostics P.E.I., Inc.
510(k) numberK202644
Submission
- Device name
- Acetaminophen
- Applicant
- Sekisui Diagnostics P.E.I., Inc.
Charlottetown, CA - Received
- September 11, 2020
- Decision date
- February 18, 2022
- 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 |
|---|---|---|---|
| K261364 | Atellica CH Acetaminophen 2 (ACTM)LDP · Traditional | Siemens Healthcare Diagnostics, Inc. | 07/24/2026SE |
| 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 |
More from Roche Diagnostics Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K182702 | SEKURE Creatine Kinase AssayCGS · Traditional | 04/17/2019SE |
| K180835 | SEKURE Acetaminophen L3K AssayLDP · Traditional | 02/08/2019SE |
| K173206 | SEKURE HbA1c AssayPDJ · Traditional | 07/12/2018SE |
| K163078 | Dc-Uibc-CalJIT · Abbreviated | 12/08/2016SE |
| K111915 | Magnesium AssayJGJ · Traditional | 12/02/2011SE |
Questions and answers
When was Acetaminophen cleared by the FDA?
Acetaminophen (K202644) received a 510(k) decision of Substantially Equivalent on February 18, 2022, 525 days after the submission was received.
What is the product code of K202644?
The FDA product code is LDP – Colorimetry, Acetaminophen, a Class II (moderate risk) device regulated under 21 CFR 862.3030.