510(k) DEN120008 ยท OYP Anti-Jcv Antibody Detection Assay
STRATIFY JCV(TM) ANTIBODY
| Applicant | Focus Diagnostics, Inc., Cypress CA, US |
| Decision | Unknown, Jan 20, 2012 |
| Received | Jan 6, 2012 |
| Type | Post-NSE |
| FDA record | Open on fda.gov |
Recalls that name DEN120008
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.