510(k) K070822
K070822 is an FDA 510(k) premarket notification submitted by Fujirebio Diagnostics,Inc. for the device "ARCHITECT SIROLIMUS ASSAY". The FDA issued a decision of Substantially Equivalent on September 28, 2007. The device falls under product code NRP (Sirolimus Test System), a Class II device regulated under 21 CFR 862.3840. Fujirebio Diagnostics,Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 28, 2007
- Date Received
- March 26, 2007
- 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.