510(k) K905531 ยท LKI Antisera, Fluorescent, Chlamydia Spp.
LUPUS(LE)-LATEX TEST
| Applicant | Immco Diagnostics, Inc., Buffalo NY, US |
| Decision | Substantially Equivalent, Jan 25, 1991 |
| Received | Dec 10, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K905531
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.