Emit & Methofrexate Assay
FDA 510(k) K833634 · Syva Co.
510(k) numberK833634
Submission
- Device name
- Emit & Methofrexate Assay
- Applicant
- Syva Co.
Mchenry, IL, US - Received
- October 17, 1983
- Decision date
- December 22, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LAO – Enzyme Immunoassay, Methotrexate
- Device class
- Unclassified
Other 510(k)s with product code LAO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K233454 | ONLINE TDM MethotrexateLAO · Traditional | Roche Diagnostics Operations | 02/20/2024SE |
| K232017 | ARK Methotrexate II AssayLAO · Traditional | Ark Diagnostics, Inc. | 12/20/2023SE |
| K163359 | ARK Methotrexate AssayLAO · Special | Ark Diagnostics, Inc. | 08/18/2017SE |
| K111904 | Ark Methotrexate Assay, Ark Methotrexate Calibrator, Ark Methotrexate Control, Ark…LAO · Traditional | Ark Diagnostics, Inc. | 10/18/2011SE |
| K932615 | Tdx(R)/Tdx(R)Flx(R)Mehtotrexate IILAO · Traditional | Abbott Laboratories | 07/14/1993SE |
| K884744 | Aca du Pont Methotrexate (Mtho) MethodLAO · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 01/30/1989SE |
| K830398 | TDX MethotrexateLAO · Traditional | Abbott Laboratories | 03/10/1983SE |
| K811459 | Emit-And Methotrexate AssayLAO · Traditional | Syva Co. | 06/09/1981SE |
| K781381 | Emit Methatrexate AssayLAO · Traditional | Dade Behring, Inc. | 10/10/1978SE |
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| K011347 | Emit 2000 Phenytoin Assay, Model 0SR4A229DIP · Special | 05/17/2001SE |
| K993981 | Syva Emit II Plus Propoxyphene Assay, Models 9G029UL/9G129ULJXN · Traditional | 02/01/2000SE |
| K993980 | Syva Emit II Plus Ethyl Alcohol Assay, Models 9K309UL/9K409ULDML · Traditional | 02/01/2000SE |
| K993988 | Syva Emit II Plus Cocaine Metabolite Assay, Model 9H029ULDIO · Traditional | 01/27/2000SE |
| K993987 | Syva Emit II Plus Barbiturate Assay, Model 9D029UL/9D129ULKLT · Traditional | 01/27/2000SE |
| K993986 | Syva Emit II Plus Methaqualone Assay, Model 9Q029UL/9Q129ULKXS · Traditional | 01/27/2000SE |
Questions and answers
When was Emit & Methofrexate Assay cleared by the FDA?
Emit & Methofrexate Assay (K833634) received a 510(k) decision of Substantially Equivalent on December 22, 1983, 66 days after the submission was received.
What is the product code of K833634?
The FDA product code is LAO – Enzyme Immunoassay, Methotrexate, a Unclassified device.