K081857 is an FDA 510(k) clearance for the DIMENSION SIRO FLEX REAGENT CARTRIDGE AND DIMENSION SIROLIMUS CALBIRATOR, MODELS DR 306, DC 306. This device is classified as a Sirolimus Test System (Class II - Special Controls, product code NRP).
Submitted by Siemens Healthcare Diagnostics, Inc. (Newark, US). The FDA issued a Cleared decision on October 30, 2008, 121 days after receiving the submission on July 1, 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 | K081857 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 01, 2008 |
| Decision Date | October 30, 2008 |
| Days to Decision | 121 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. |