510(k) K955157 ยท MHI Giardia Spp.
PROSPECT GIARDIA/CRYPTOSPORIDIUM MICROPLATE ASSAY
| Applicant | Alexon Biomedical, Inc., Sunnyvale CA, US |
| Decision | Substantially Equivalent, Feb 9, 1996 |
| Received | Nov 13, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K955157
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 17, 2004 | Remel, Inc. ProSpecT Giardia/Cryptosporidium Micorplate Assay. Catalog #: 2458496. Terminated |
MHI | None listed |
| Aug 17, 2004 | Remel, Inc. ProSpecT Giardia/Cryptosporidium Microplate Assay. Catalog #: 2458496. Terminated |
MHI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.