510(k) K060385 ยท MLM Enzyme Immunoassay, Tracrolimus
EMIT 2000 TACROLIMUS ASSAY AND SAMPLE PRETREATMENT REAGENT
| Applicant | Dade Behring, Inc., Newark DE, US |
| Decision | Substantially Equivalent, Apr 6, 2006 |
| Received | Feb 14, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K060385
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 29, 2017 | Siemens Healthcare Diagnostics, Inc. Syva Emit 2000 Tacrolimus Assay (Product Number: 8R019UL/10445397) (Mfr: Siemens Healthcare Diagnostics, Newark, DE) Terminated |
MLM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.