510(k) K912239 ยท GQW Antigen, Cf, (Including Cf Control), Varicella-Zoster
VZVSCAN(TM) LATEX AGGUTINATION TEST
| Applicant | Bd Becton Dickinson Vacutainer Systems Preanalytic, Franklin Lakes NJ, US |
| Decision | Substantially Equivalent, Jun 11, 1991 |
| Received | May 21, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K912239
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.