510(k) K883939 ยท LIP Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
ORTHO* SYPHILIS-G ANTIBODY ELISA TEST
| Applicant | Ortho Diagnostic Systems, Inc., Carpinteria CA, US |
| Decision | Substantially Equivalent, Dec 22, 1988 |
| Received | Sep 19, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K883939
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.