510(k) K893954
K893954 is an FDA 510(k) premarket notification submitted by Microgenics Corp. for the device "CEDIA CORTISOL ASSAY". The FDA issued a decision of Substantially Equivalent on Oct 31, 1989. The device falls under product code JFT (Fluorometric, Cortisol), a Class II device regulated under 21 CFR 862.1205. Microgenics Corp. has 106 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 31, 1989
- Date Received
- Jun 1, 1989
- 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
- 510(k)