510(k) K153730 ยท LIP Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
ARCHITECT Syphilis TP Reagent, ARCHITECT Syphilis TP Calibrator, ARCHITECT Syphilis TP Control
| Applicant | Abbott Laboratories, Abbott Park IL, US |
| Decision | Substantially Equivalent, Jun 15, 2016 |
| Received | Dec 28, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K153730
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.