510(k) K821931
K821931 is an FDA 510(k) premarket notification submitted by Amf Biological And Diagnostics Co. for the device "ZETA-CORT". The FDA issued a decision of Substantially Equivalent on Jul 22, 1982. The device falls under product code CGR (Radioimmunoassay, Cortisol), a Class II device regulated under 21 CFR 862.1205. Amf Biological And Diagnostics Co. has 4 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 22, 1982
- Date Received
- Jun 29, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Radioimmunoassay, Cortisol
- Device Class
- Class II
- Regulation Number
- 862.1205
- Review Panel
- CH
- Submission Type
- 510(k)