510(k) K962559
K962559 is an FDA 510(k) premarket notification submitted by Ciba Corning Diagnostics Corp. for the device "ACS CORTISOL IMMUNOASSAY". The FDA issued a decision of Substantially Equivalent on November 5, 1996. The device falls under product code JFT (Fluorometric, Cortisol), a Class II device regulated under 21 CFR 862.1205. Ciba Corning Diagnostics Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 5, 1996
- Date Received
- July 1, 1996
- 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