510(k) K093383 ยท OOI Real Time Nucleic Acid Amplification System
NUCLISENS EASYQ ENTEROVIRUS V1.1., NUCLISENS EASYQ DIRECTOR 2.6, NUCLISENS EASYQ ANALYZER, NUCLISENS MINIMAG
| Applicant | bioMerieux, Inc., Durham NC, US |
| Decision | Substantially Equivalent, Jul 6, 2010 |
| Received | Oct 30, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K093383
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 6, 2011 | bioMerieux, Inc. NucliSens EasyQ Enterovirus serotype 68 v1.1: Catalog number: 200300
In Vitro Diagnostic Test Terminated |
OOI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.