510(k) K081857
K081857 is an FDA 510(k) premarket notification submitted by Siemens Healthcare Diagnostics, Inc. for the device "DIMENSION SIRO FLEX REAGENT CARTRIDGE AND DIMENSION SIROLIMUS CALBIRATOR, MODELS DR 306, DC 306". The FDA issued a decision of Substantially Equivalent on October 30, 2008. The device falls under product code NRP (Sirolimus Test System), a Class II device regulated under 21 CFR 862.3840. Siemens Healthcare Diagnostics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 30, 2008
- Date Received
- July 1, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Sirolimus Test System
- Device Class
- Class II
- Regulation Number
- 862.3840
- Review Panel
- TX
- Submission Type
Sirolimus test systems are intended for the quantitative measurement of sirolimus in whole blood as an aid in management of transplant patients taking this sirolimus.