510(k) K102400 ยท LIP Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
SYPHILIS HEALTH CHECK
| Applicant | Diagnostics Direct, LLC, East Stroudsburg PA, US |
| Decision | Substantially Equivalent, Aug 1, 2011 |
| Received | Aug 24, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K102400
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.