510(k) K081992
K081992 is an FDA 510(k) premarket notification submitted by Siemens Healthcare Diagnostics, Inc. for the device "DIMENSION VISTA CSAE FLEX REGENT CARTRIDGE, MODEL K4108". The FDA issued a decision of Substantially Equivalent on August 5, 2008. The device falls under product code MKW (Cyclosporine), a Class II device regulated under 21 CFR 862.1235. Siemens Healthcare Diagnostics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 5, 2008
- Date Received
- July 14, 2008
- Clearance Type
- Special
- 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