510(k) K912754
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 27, 1991
- Date Received
- June 21, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Radioimmunoassay, Amphetamine (125-I), Goat Antibody, Ammonium Sulfate Sep.
- Device Class
- Class II
- Regulation Number
- 862.3100
- Review Panel
- TX
- Submission Type