TDX(R)/TDX(R)FLX(R)MEHTOTREXATE II
FDA 510(k) clearance K932615 · decided 1993-07-14
Clearance details
- K-number
- K932615
- Device name
- TDX(R)/TDX(R)FLX(R)MEHTOTREXATE II
- Applicant
- Abbott Laboratories
- Decision
- Substantially Equivalent
- Date received
- 1993-06-01
- Decision date
- 1993-07-14
- Days to decision
- 43 days
- Clearance type
- Traditional
- Product code
- LAO
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Abbott Park, 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 |
| 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-AND METHOTREXATE ASSAY (K811459) | Syva Co. | 1981-06-09 |
| EMIT METHATREXATE ASSAY (K781381) | Dade Behring, Inc. | 1978-10-10 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| TDx/TDxFLx Methotrexate II Reagent-List Number 07A12-60 - a reagent system for In Vitro di recall (Z-1056-2007) | Abbott Diagnostic International, Ltd. | 2007-07-20 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| ARCHITECT AFP; Alinity i AFP (LN 3P36/07P90) (P120008/S032) | Abbott Laboratories | 2026-05-11 |
| ARCHITECT Total PSA / Alinity i Total PSA (LN 6C06/07P92) (P910007/S068) | Abbott Laboratories | 2026-02-23 |
| ARCHITECT Free PSA; Alinity i Free PSA (LN 6C07/07P93) (P980007/S056) | Abbott Laboratories | 2026-02-12 |
| ARCHITECT Total PSA; Alinity i Total PSA (LN 6C06/07P92) (P910007/S067) | Abbott Laboratories | 2026-02-12 |
| ARCHITECT AFP; Alinity i AFP (LN 3P36/07P90) (P120008/S031) | Abbott Laboratories | 2026-02-12 |
| ARCHITECT CORE / Alinity i Anti-HBc (P080023/S046) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT AFP / Alinity i AFP (P120008/S030) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT CORE-M / Alinity i Anti-HBc IgM (P060035/S043) | Abbott Laboratories | 2025-04-03 |