510(k) K040761
K040761 is an FDA 510(k) premarket notification submitted by Abbott Laboratories, Inc. for the device "AXSYM CYCLOSPORINE". The FDA issued a decision of Substantially Equivalent on April 30, 2004. The device falls under product code MKW (Cyclosporine), a Class II device regulated under 21 CFR 862.1235. Abbott Laboratories, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 30, 2004
- Date Received
- March 25, 2004
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cyclosporine
- Device Class
- Class II
- Regulation Number
- 862.1235
- Review Panel
- TX
- Submission Type