510(k) K103766 ยท OQW 2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification
XPERT FLU, GENEXPERT DX SYSTEMS, GENEXPERT INFINITY SYSTEM, GENEXPERT SYSTEM SOFTWARE VERISIONS 2.1 AND 4.0
| Applicant | Cepheid, Sunnyvale CA, US |
| Decision | Substantially Equivalent, Apr 21, 2011 |
| Received | Dec 23, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K103766
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 31, 2011 | Cepheid Xpert Infinity Software, V 4.1a.
Cepheid, Sunnyvale, CA 94089
system software for GeneXpert Infinity 48 Terminated |
NJR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.