510(k) K083487 ยท NRP Sirolimus Test System
EMIT 2000 SIROLIMUS ASSAY, EMIT 2000 SIRO/TACRO SAMPLE PRETREATMENT REAGENT, AND EMIT 200 SIROLIMUS CALIBRATOR
| Applicant | Siemens Healthcare Diagnostics, Newark DE, US |
| Decision | Substantially Equivalent, Mar 30, 2009 |
| Received | Nov 25, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083487
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 29, 2017 | Siemens Healthcare Diagnostics, Inc. Syva Emit 2000 Sirolimus Assay (Product Number: 8S019UL/10445401) (Mfr: Siemens Healthcare Diagnostics, Newark, DE) Terminated |
NRP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.