510(k) K922676
K922676 is an FDA 510(k) premarket notification submitted by Nichols Institute for the device "CORTISOL CHEMILUMINESCENCE ASSAY". The FDA issued a decision of Substantially Equivalent on July 10, 1992. The device falls under product code CGR (Radioimmunoassay, Cortisol), a Class II device regulated under 21 CFR 862.1205. Nichols Institute has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 10, 1992
- Date Received
- June 4, 1992
- 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