TDX(R)/TDXFLX(R) FREE PHENYTOIN II
FDA 510(k) clearance K950280 · decided 1995-05-02
Clearance details
- K-number
- K950280
- Device name
- TDX(R)/TDXFLX(R) FREE PHENYTOIN II
- Applicant
- Abbott Laboratories
- Decision
- Substantially Equivalent
- Date received
- 1995-01-24
- Decision date
- 1995-05-02
- Days to decision
- 98 days
- Clearance type
- Traditional
- Product code
- MOJ
- Device class
- 2
- Regulation number
- 862.3350
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- 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 Phenytoin - Free Phenytoin application (K230161) | Roche Diagnostics | 2023-03-30 |
| COBAS-FP APPLICATION FOR FREE PHENYTOIN, COBAS-FP PHENYTOIN CALIBRATORS, & CONTROLS (K952555) | Roche Diagnostic Systems, Inc. | 1995-07-31 |
Recalls involving this device
No recalls on record reference this clearance.
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 |