EMIT-AND METHOTREXATE ASSAY
FDA 510(k) clearance K811459 · decided 1981-06-09
Clearance details
- K-number
- K811459
- Device name
- EMIT-AND METHOTREXATE ASSAY
- Applicant
- Syva Co.
- Decision
- Substantially Equivalent
- Date received
- 1981-05-26
- Decision date
- 1981-06-09
- Days to decision
- 14 days
- Clearance type
- Traditional
- Product code
- LAO
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ONLINE TDM Methotrexate (K233454) | Roche Diagnostics Operations | 2024-02-20 |
| ARK Methotrexate II Assay (K232017) | Ark Diagnostics, Inc. | 2023-12-20 |
| ARK Methotrexate Assay (K163359) | Ark Diagnostics, Inc. | 2017-08-18 |
| ARK METHOTREXATE ASSAY, ARK METHOTREXATE CALIBRATOR, ARK METHOTREXATE CONTROL, ARK METHOTREXATE CONTROL (CALIBRATION RAN (K111904) | Ark Diagnostics, Inc. | 2011-10-18 |
| TDX(R)/TDX(R)FLX(R)MEHTOTREXATE II (K932615) | Abbott Laboratories | 1993-07-14 |
| ACA DU PONT METHOTREXATE (MTHO) METHOD (K884744) | E.I. Dupont DE Nemours & Co., Inc. | 1989-01-30 |
| EMIT & METHOFREXATE ASSAY (K833634) | Syva Co. | 1983-12-22 |
| TDX METHOTREXATE (K830398) | Abbott Laboratories | 1983-03-10 |
| EMIT METHATREXATE ASSAY (K781381) | Dade Behring, Inc. | 1978-10-10 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Syva Emit Methotrexate Assay, is a homogeneous enzyme immunoassay intended for use in the recall (Z-1618-2016) | Siemens Healthcare Diagnostics, Inc. | 2016-05-06 |