510(k) K941409 ยท LJM Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
ENA PROFILE-6 ELISA TEST SYSTEM
| Applicant | Zeus Scientific, Inc., Raritan NJ, US |
| Decision | Substantially Equivalent, Jun 10, 1994 |
| Received | Mar 23, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K941409
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 31, 2009 | Zeus Scientific Inc Sm ELISA Test System
Product number 2Z2831G and Product number 43270CE
Individual Enzyme-Linked Immunosorbent Assays for Antibodies to Jo-1, SM, SM/RNP, SSA, SSB and Scl-70.
Manufactured by Zeus Scien Terminated |
LJM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.