510(k) K895468 ยท LJC Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group)
ORGENICS IMMUNOCOMB(TM) CHLAMYDIA TRACHOMATIS IGG
| Applicant | Orgenics, Ltd., Columbia MD, US |
| Decision | Substantially Equivalent, Mar 13, 1990 |
| Received | Sep 11, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K895468
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.