510(k) K922581 ยท LFX Enzyme Linked Immunoabsorbent Assay, Rubella
BARTELS RUBELLA IGM EIA
| Applicant | Baxter Diagnostics, Inc., Bellevue WA, US |
| Decision | Substantially Equivalent, Sep 17, 1992 |
| Received | May 27, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K922581
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.