510(k) K965092 ยท LIQ Enzyme Linked Immunoabsorbent Assay, Rotavirus
VIDAS ROTAVIRUS ASSAY
| Applicant | Biomerieux Vitek, Inc., Rockland MA, US |
| Decision | Substantially Equivalent, May 5, 1997 |
| Received | Dec 19, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K965092
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.