510(k) K935129 ยท LLL Extractable Antinuclear Antibody, Antigen And Control
RELISA ENA ANTIBODY SCREENING TEST SYSTEM
| Applicant | Immuno Concepts, Inc., Sacramento CA, US |
| Decision | Substantially Equivalent, Jan 31, 1994 |
| Received | Oct 28, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K935129
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 6, 2009 | Immuno Concepts Inc RELISA ENA Multiparameter Antibody Screening test, enzyme immunoassay test system, manufactured by Immuno Concepts N.A. Ltd., Sacramento, CA. Terminated |
LLL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.