510(k) K910154
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 9, 1991
- Date Received
- January 14, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Radioimmunoassay, Digoxin (3-H), Goat Antibody, 2nd Antibody Sep.
- Device Class
- Class II
- Regulation Number
- 862.3320
- Review Panel
- TX
- Submission Type