510(k) K081064 ยท MHI Giardia Spp.
GIARDIA FECAL ANTIGEN DETECTION LATERAL FLOW KIT, MODEL GL-LF
| Applicant | Ivd Research, Inc., Tucson AZ, US |
| Decision | Substantially Equivalent, Jan 14, 2009 |
| Received | Apr 14, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K081064
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.