510(k) K960367 ยท LFX Enzyme Linked Immunoabsorbent Assay, Rubella
INCSTAR RUBELLA IGG ELISA ASSAY
| Applicant | Incstar Corp., Stillwater MN, US |
| Decision | Substantially Equivalent, Oct 24, 1996 |
| Received | Jan 25, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K960367
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 2, 2010 | Diasorin Inc. DiaSorin Rubella IgG ELISA Kit, Cat. # 7545, 2 x 6 Wells, DiaSorin Inc., 1951 northwestern Avenue, Stillwater, MN 55082-0285, Lot 123127A, Exp. 2010//07/28. Terminated |
LFX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.