510(k) K820616
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 26, 1982
- Date Received
- March 8, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Radioimmunoassay, Angiotensin I And Renin
- Device Class
- Class II
- Regulation Number
- 862.1085
- Review Panel
- CH
- Submission Type