510(k) K031834 ยท MHI Giardia Spp.
XPECT GIARDIA/CRYPTOSPORIDIUM LATERAL FLOW ASSAY
| Applicant | Remel, Inc., Lenexa KS, US |
| Decision | Substantially Equivalent, Nov 10, 2003 |
| Received | Jun 13, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K031834
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 19, 2008 | Remel, Inc Xpect Giardia/Cryptosporidium Kit, Ref 24050520, 20 tests per kit, For In Vitro Diagnostic Use.
A rapid test for the direct qualitative detection of Giardia and Cryptosporidium antigens in fecal spec Terminated |
MHI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.