510(k) K962558 ยท LJC Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group)
CHLAMYDIA IGG ELISA TEST SYSTEM
| Applicant | Armkel, LLC, Frederick MD, US |
| Decision | Substantially Equivalent, Feb 24, 1997 |
| Received | Jul 1, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K962558
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.