510(k) K921321 ยท LJC Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group)
ORTHO CHLAMYDIA ANTIGEN ELISA TEST
| Applicant | Ortho Diagnostic Systems, Inc., Carpinteria CA, US |
| Decision | Substantially Equivalent, Aug 11, 1992 |
| Received | Mar 16, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K921321
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.