510(k) K880824 ยท LJC Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group)
PATHFINDER(TM) CHLAMYDIA EIA DETECTION KIT
| Applicant | Kallestad Diag, A Div. of Erbamont, Inc., Chaska MN, US |
| Decision | Substantially Equivalent, Apr 12, 1988 |
| Received | Mar 1, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K880824
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.