510(k) K900973 ยท LJC Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group)
VISUWELL(R) CHLAMYDIA
| Applicant | Adi Diagnostics, Inc., Rexdale, Ontario, CA |
| Decision | Substantially Equivalent, May 15, 1990 |
| Received | Mar 2, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K900973
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.