510(k) K910178
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 22, 1991
- Date Received
- January 15, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Radioimmunoassay, Acth
- Device Class
- Class II
- Regulation Number
- 862.1025
- Review Panel
- CH
- Submission Type