510(k) K904725 ยท LJC Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group)
CHLAMYDIA SYSTEM SOFTWARE (CSS)
| Applicant | Kallestad Diag, A Div. of Erbamont, Inc., Chaska MN, US |
| Decision | Substantially Equivalent, Jan 14, 1991 |
| Received | Oct 17, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K904725
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.