Panels › Clinical Toxicology › Product code NRP · Class 2
Sirolimus Test System
Regulation 862.3840
0510(k)s in 12 months (5 all time)
0recalls in 12 months (6 all time)
6recalls that name a 510(k)
Top companies in NRP
| Company | 510(k)s | Recalls |
|---|---|---|
| Siemens Healthcare Diagnostics | 2 | 3 |
| Abbott Laboratories | 0 | 2 |
| Abbott Laboratories MPG | 0 | 1 |
| Axis-Shield , Ltd. | 1 | 0 |
| Fujirebio Diagnostics,Inc. | 1 | 0 |
| Microgenics Corp. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 30, 2009 | K083487 | EMIT 2000 SIROLIMUS ASSAY, EMIT 2000 SIRO/TACRO SAMPLE PRETREATMENT REAGENT, AND EMIT 200 SIROLIMUS CALIBRATOR Siemens Healthcare Diagnostics | NRP |
| Oct 30, 2008 | K081857 | DIMENSION SIRO FLEX REAGENT CARTRIDGE AND DIMENSION SIROLIMUS CALBIRATOR, MODELS DR 306, DC 306 Siemens Healthcare Diagnostics, Inc. | NRP |
| Sep 28, 2007 | K070822 | ARCHITECT SIROLIMUS ASSAY Fujirebio Diagnostics,Inc. | NRP |
| Apr 7, 2005 | K042411 | ABBOTT IMX SIROLIMUS MICROPARTICLE ENZYME IMMUNOASSAY Axis-Shield , Ltd., GB | NRP |
| Jul 28, 2004 | DEN040008 | CEDIA SIROLIMUS ASSAY Microgenics Corp. | NRP |
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