510(k) K052359
K052359 is an FDA 510(k) premarket notification submitted by Lehnus & Associates Consulting for the device "IBL CORTISOL LIA TEST KIT". The FDA issued a decision of Substantially Equivalent on October 3, 2005. The device falls under product code CGR (Radioimmunoassay, Cortisol), a Class II device regulated under 21 CFR 862.1205. Lehnus & Associates Consulting has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 3, 2005
- Date Received
- August 26, 2005
- 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