510(k) K950227 ยท LFX Enzyme Linked Immunoabsorbent Assay, Rubella
RUBELISA (RUBESTAT)
| Applicant | Bio-Whittaker, Inc., A Cambrex Co., Walkersville MD, US |
| Decision | Substantially Equivalent, Aug 15, 1995 |
| Received | Jan 10, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K950227
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.