510(k) K982315 ยท LQP Campylobacter Spp.
PROSPECT CAMPYLOBACTER MICROPLATE ASSAY
| Applicant | Alexon - Trend, Inc., Ramsey MN, US |
| Decision | Substantially Equivalent, Nov 18, 1998 |
| Received | Jul 1, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K982315
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 17, 2004 | Remel, Inc. ProSpecT Campylobacter Microplate Assay. Catalog #2476096. Terminated |
LQP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.