NRP — Sirolimus Test System Class II
Classification Details
- Product Code
- NRP
- Device Class
- Class II
- Regulation Number
- 862.3840
- Submission Type
- Review Panel
- TX
- Medical Specialty
- Clinical Toxicology
- Implant
- No
Definition
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K083487 | siemens healthcare diagnostics | EMIT 2000 SIROLIMUS ASSAY, EMIT 2000 SIRO/TACRO SAMPLE PRETREATMENT REAGENT, AND | March 30, 2009 |
| K081857 | siemens healthcare diagnostics | DIMENSION SIRO FLEX REAGENT CARTRIDGE AND DIMENSION SIROLIMUS CALBIRATOR, MODELS | October 30, 2008 |
| K070822 | fujirebio diagnostics | ARCHITECT SIROLIMUS ASSAY | September 28, 2007 |
| K042411 | axis-shield | ABBOTT IMX SIROLIMUS MICROPARTICLE ENZYME IMMUNOASSAY | April 7, 2005 |
| DEN040008 | microgenics | CEDIA SIROLIMUS ASSAY | July 28, 2004 |