510(k) K062626
K062626 is an FDA 510(k) premarket notification submitted by Ibl-Hamburg GmbH for the device "CORTISOL ELISA". The FDA issued a decision of Substantially Equivalent on December 20, 2006. The device falls under product code CGR (Radioimmunoassay, Cortisol), a Class II device regulated under 21 CFR 862.1205. Ibl-Hamburg GmbH has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 20, 2006
- Date Received
- September 5, 2006
- 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