510(k) K961317 ยท LIP Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
SYPHILIS IGM HUMAN SERUM CONTROLS
| Applicant | Pyramid Biological Corp., Van Nuys CA, US |
| Decision | Substantially Equivalent, Jun 24, 1996 |
| Received | Apr 5, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K961317
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.