510(k) K903132 ยท LJC Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group)
ORTHO CHLAMYDIA ANTIGEN ELISA/ELISA CULT EXTRA BUF
| Applicant | Ortho Diagnostic Systems, Inc., Raritan NJ, US |
| Decision | Substantially Equivalent, Dec 21, 1990 |
| Received | Jul 17, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K903132
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.