510(k) K142325
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 18, 2014
- Date Received
- August 20, 2014
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Calibrator, Dose, Radionuclide
- Device Class
- Class II
- Regulation Number
- 892.1360
- Review Panel
- RA
- Submission Type