K083487 is an FDA 510(k) clearance for the EMIT 2000 SIROLIMUS ASSAY, EMIT 2000 SIRO/TACRO SAMPLE PRETREATMENT REAGENT, AND EMIT 200 SIROLIMUS CALIBRATOR. This device is classified as a Sirolimus Test System (Class II - Special Controls, product code NRP).
Submitted by Siemens Healthcare Diagnostics (Newark, US). The FDA issued a Cleared decision on March 30, 2009, 125 days after receiving the submission on November 25, 2008.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3840. 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..
| 510(k) Number | K083487 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 25, 2008 |
| Decision Date | March 30, 2009 |
| Days to Decision | 125 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | NRP — Sirolimus Test System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3840 |
| 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. |