510(k) K854615 ยท LKI Antisera, Fluorescent, Chlamydia Spp.
MONABRITE CHLAMYDIA TRACH CULTURE CONFIRMATION TES
| Applicant | Serono Diagnostics, Inc., Bramtree MA, US |
| Decision | Substantially Equivalent, Jan 28, 1986 |
| Received | Nov 18, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K854615
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.