510(k) K031965 ยท MHJ Cryptosporidium Spp.
XPECT CRYPTOSPORIDIUM LATERAL FLOW ASSAY, MODEL 2451020
| Applicant | Remel, Inc., Ramsey MN, US |
| Decision | Substantially Equivalent, Nov 14, 2003 |
| Received | Jun 26, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K031965
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 17, 2004 | Remel, Inc. ProSpecT Cryptosporidium Microplate Assay. Catalog #2454096. Terminated |
MHJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.