510(k) K884744
- Device
- ACA DU PONT METHOTREXATE (MTHO) METHOD
- Applicant
- E.I. DUPONT DE NEMOURS & CO., INC.
- 510(k) number
- K884744
- Product code
- LAO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1989-01-30
- Date received
- 1988-11-14
- Regulation
- 510(k) Premarket Notification
- Classification name
- Enzyme Immunoassay, Methotrexate
- Medical specialty
- 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
- Review panel
- Toxicology
- Device class
- U
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- CHRISTOPHER BENTSEN
- Address
- Du Pont-Bmp22/1152 Wilmington DE US 19880 19880
FDA Registration Numbers#
- 3005755244
- 9610126
- 2517506
- 2521625
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LAO #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K233454 | ONLINE TDM Methotrexate | Roche Diagnostics Operations | 2024-02-20 |
| K232017 | ARK Methotrexate II Assay | Ark Diagnostics, Inc. | 2023-12-20 |
| K163359 | ARK Methotrexate Assay | Ark Diagnostics, Inc. | 2017-08-18 |
| K111904 | ARK METHOTREXATE ASSAY, ARK METHOTREXATE CALIBRATOR, ARK METHOTREXATE CONTROL, ARK METHOTREXATE CONTROL (CALIBRATION RAN | Ark Diagnostics, Inc. | 2011-10-18 |
| K932615 | TDX(R)/TDX(R)FLX(R)MEHTOTREXATE II | Abbott Laboratories | 1993-07-14 |
| K833634 | EMIT & METHOFREXATE ASSAY | Syva Co. | 1983-12-22 |
| K830398 | TDX METHOTREXATE | Abbott Laboratories | 1983-03-10 |
| K811459 | EMIT-AND METHOTREXATE ASSAY | Syva Co. | 1981-06-09 |
| K781381 | EMIT METHATREXATE ASSAY | Dade Behring, Inc. | 1978-10-10 |
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases