ONLINE TDM Phenytoin - Free Phenytoin application
FDA 510(k) clearance K230161 · decided 2023-03-30
Clearance details
- K-number
- K230161
- Device name
- ONLINE TDM Phenytoin - Free Phenytoin application
- Applicant
- Roche Diagnostics
- Decision
- Substantially Equivalent
- Date received
- 2023-01-20
- Decision date
- 2023-03-30
- Days to decision
- 69 days
- Clearance type
- Traditional
- Product code
- MOJ
- Device class
- 2
- Regulation number
- 862.3350
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Indianapolis, IN, 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 |
|---|---|---|
| COBAS-FP APPLICATION FOR FREE PHENYTOIN, COBAS-FP PHENYTOIN CALIBRATORS, & CONTROLS (K952555) | Roche Diagnostic Systems, Inc. | 1995-07-31 |
| TDX(R)/TDXFLX(R) FREE PHENYTOIN II (K950280) | Abbott Laboratories | 1995-05-02 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Elecsys Anti-HBs II, PreciControl Anti-HBs (P190034/S010) | Roche Diagnostics | 2025-05-22 |
| Elecsys Anti-HBe (P190005/S007) | Roche Diagnostics | 2025-05-22 |
| Elecsys Anti-HBe (P190005/S006) | Roche Diagnostics | 2024-10-03 |
| Elecsys Anti-HBs / Elecsys HBs II (P190034/S009) | Roche Diagnostics | 2024-10-03 |
| Elecsys Anti-HBs II (P190034/S008) | Roche Diagnostics | 2024-08-29 |
| Elecsys Anti-HBe (P190005/S005) | Roche Diagnostics | 2024-08-29 |
| Elecsys Anti-HBs II, PreciControl Anti-HBs (P190034/S007) | Roche Diagnostics | 2024-07-23 |
| Elecsys Anti-HBs II, PreciControl Anti-HBs (P190034/S005) | Roche Diagnostics | 2024-05-01 |