510(k) K912143 ยท LFW Fluorescence Polarization Immunoassay, Tobramycin
CEDIA(R) TOBRAMYCIN ASSAY
| Applicant | Microgenics Corp., Concord CA, US |
| Decision | Substantially Equivalent, Jul 26, 1991 |
| Received | May 15, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K912143
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 16, 2013 | Microgenics Corp Thermo Fisher Scientific/Microgenics brand CEDIA Tobramycin II Assay, Catalog Number 100018, Product is manufactured and distributed by
Microgenics Corporation, located at Fremont, CA., part of Therm Terminated |
LFW | None listed |
| Feb 28, 2006 | Roche Diagnostics Corp. Roche brand CEDIA Tobramycin II Reagent, Catalog # 1815385, Material # 11815385216. Terminated |
LFW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.