510(k) DEN040008
DEN040008 is an FDA 510(k) premarket notification submitted by Microgenics Corp. for the device "CEDIA SIROLIMUS ASSAY". The FDA issued a decision of De Novo Granted on July 28, 2004. The device falls under product code NRP (Sirolimus Test System), a Class II device regulated under 21 CFR 862.3840. Microgenics Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- July 28, 2004
- Date Received
- June 17, 2004
- Clearance Type
- Post-NSE
- 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.