Acetaminophen Assay for the Advia Integrated Modular System
FDA 510(k) K020792 · Bayer Diagnostics Corp.
510(k) numberK020792
Submission
- Device name
- Acetaminophen Assay for the Advia Integrated Modular System
- Applicant
- Bayer Diagnostics Corp.
Tarrytown, NY, US - Received
- March 11, 2002
- Decision date
- July 11, 2002
- 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 |
| 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 |
| K013757 | Roche AcetaminophenLDP · Traditional | Roche Diagnostics Corp. | 01/08/2002SE |
More from Roche Diagnostics Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K033379 | Bayer Special Chemistry ControlsJJY · Abbreviated | 12/19/2003SE |
| K033380 | Bayer Special Chemistry CalibratorsJIX · Abbreviated | 12/16/2003SE |
| K033007 | Bayer Advia Digoxin Assay for the Integrated Module SystemKXT · Traditional | 11/14/2003SE |
| K031857 | Advia Chemistry ALPHA-1 Antitrypsin AssayDEM · Traditional | 09/04/2003SE |
| K022096 | Uric Acid Assay for the Advia Integrated Modular SystemKNK · Traditional | 03/18/2003SE |
| K030452 | Bayer Ligand Plus 1, 2, 3 ControlsJJY · Abbreviated | 03/03/2003SE |
| K023840 | Acid Phosphatase Assay for the Advia 1650CKB · Traditional | 01/07/2003SE |
| K023841 | Ammonia Assay for the Advia 1650JIF · Traditional | 12/24/2002SE |
| K022177 | Prostate Specific Antigen (Psa) Assay for the Advia Integrated Modular SystemLTJ · Traditional | 12/17/2002SE |
| K022329 | Ca 125 II Assay for the Bayer Advia Integrated Module SystemLTK · Traditional | 11/27/2002SE |
Questions and answers
When was Acetaminophen Assay for the Advia Integrated Modular System cleared by the FDA?
Acetaminophen Assay for the Advia Integrated Modular System (K020792) received a 510(k) decision of Substantially Equivalent on July 11, 2002, 122 days after the submission was received.
What is the product code of K020792?
The FDA product code is LDP – Colorimetry, Acetaminophen, a Class II (moderate risk) device regulated under 21 CFR 862.3030.