510(k) K954591
K954591 is an FDA 510(k) premarket notification submitted by Tosoh Medics, Inc. for the device "AIA-PACK CORT ASSAY". The FDA issued a decision of Substantially Equivalent on December 15, 1995. The device falls under product code JFT (Fluorometric, Cortisol), a Class II device regulated under 21 CFR 862.1205. Tosoh Medics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 15, 1995
- Date Received
- October 2, 1995
- 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