510(k) K862948 ยท LJC Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group)
CHLAMYDIA TISSUE CULTURE CONFIRMATION TEST (EIA)
| Applicant | Intercare Diagnostics, Inc., Berkeley CA, US |
| Decision | Substantially Equivalent, Oct 17, 1986 |
| Received | Aug 5, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K862948
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.