510(k) K894845 ยท GMD Antisera, Latex Agglutination, Cryptococcus Neoformans
(CALAS(TM)) W/ADD'L REAGENT CALAS(TM) PRONASE
| Applicant | Meridian Diagnostics, Inc., Cincinnati OH, US |
| Decision | Substantially Equivalent, Sep 8, 1989 |
| Received | Aug 11, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K894845
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.