510(k) K892202 ยท LFX Enzyme Linked Immunoabsorbent Assay, Rubella
DETECTADOT(TM) SYSTEM 2000 RUBELLA IGG TEST
| Applicant | Gull Laboratories, Inc., Salt Lake City UT, US |
| Decision | Substantially Equivalent, Sep 13, 1989 |
| Received | Apr 3, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K892202
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.