510(k) K863490 ยท LJC Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group)
ORTHO* CHLAMYDIA ANTIGEN ELISA TEST & TRANSPORT
| Applicant | Ortho Diagnostic Systems, Inc., Carpinteria CA, US |
| Decision | Substantially Equivalent, Nov 5, 1986 |
| Received | Sep 9, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K863490
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.