510(k) K132631 ยท LKP Anti-Sm Antibody, Antigen And Control
EIA SMDP IMMUNOASSAY
| Applicant | Phadia US, Inc., Portage MI, US |
| Decision | Substantially Equivalent, Aug 29, 2014 |
| Received | Aug 22, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K132631
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 28, 2016 | Phadia Ab EliA SmDP Well, Article Number 14-5624-01
Product Usage:
EliA SmDP is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to Sm in human serum and plasma (EDTA, citrate Terminated |
LKP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.