LITHIUM MICRO VOLUME ELECTRODE, THEOPHYLLINE, ISE CALIBRATORS 1, 2 AND 3, TDM CALIBRATION SET B, NORTROL AND ABTROL
FDA 510(k) clearance K063705 · decided 2007-10-09
Clearance details
- K-number
- K063705
- Device name
- LITHIUM MICRO VOLUME ELECTRODE, THEOPHYLLINE, ISE CALIBRATORS 1, 2 AND 3, TDM CALIBRATION SET B, NORTROL AND ABTROL
- Applicant
- Thermo Electron OY
- Decision
- Substantially Equivalent
- Date received
- 2006-12-13
- Decision date
- 2007-10-09
- Days to decision
- 300 days
- Clearance type
- Traditional
- Product code
- NDW
- Device class
- 2
- Regulation number
- 862.3560
- 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.