510(k) K863422
K863422 is an FDA 510(k) premarket notification submitted by Lkb Instruments, Inc. for the device "DELFIA(TM) CORTISOL KIT". The FDA issued a decision of Substantially Equivalent on September 26, 1986. The device falls under product code JFT (Fluorometric, Cortisol), a Class II device regulated under 21 CFR 862.1205. Lkb Instruments, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 26, 1986
- Date Received
- September 4, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Fluorometric, Cortisol
- Device Class
- Class II
- Regulation Number
- 862.1205
- Review Panel
- CH
- Submission Type