510(k) K914468
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 30, 1991
- Date Received
- October 7, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Radioimmunoassay, Barbiturate
- Device Class
- Class II
- Regulation Number
- 862.3150
- Review Panel
- TX
- Submission Type