K070822 is an FDA 510(k) clearance for the ARCHITECT SIROLIMUS ASSAY. This device is classified as a Sirolimus Test System (Class II - Special Controls, product code NRP).
Submitted by Fujirebio Diagnostics,Inc. (Malvern, US). The FDA issued a Cleared decision on September 28, 2007, 186 days after receiving the submission on March 26, 2007.
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 | K070822 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 26, 2007 |
| Decision Date | September 28, 2007 |
| Days to Decision | 186 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. |