PHENOBARBITAL, PHENYTOIN, TDM CALIBRATION SET B AND ABTROL/NORTROL CONTROLS
FDA 510(k) clearance K063145 · decided 2007-10-17
Clearance details
- K-number
- K063145
- Device name
- PHENOBARBITAL, PHENYTOIN, TDM CALIBRATION SET B AND ABTROL/NORTROL CONTROLS
- Applicant
- Thermo Electron OY
- Decision
- Substantially Equivalent
- Date received
- 2006-10-16
- Decision date
- 2007-10-17
- Days to decision
- 366 days
- Clearance type
- Traditional
- Product code
- DIP
- Device class
- 2
- Regulation number
- 862.3350
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Vantaa, FI
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.