510(k) K010790
K010790 is an FDA 510(k) premarket notification submitted by Kmi Diagnostics, Inc. for the device "CORTISOL LIA". The FDA issued a decision of Substantially Equivalent on January 29, 2002. The device falls under product code CGR (Radioimmunoassay, Cortisol), a Class II device regulated under 21 CFR 862.1205. Kmi Diagnostics, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 29, 2002
- Date Received
- March 15, 2001
- 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