510(k) K820643 ยท LIZ Assay, T Lymphocyte Surface Marker
ORTHO SPECTRUM III & ORTHO-MUNE OK
| Applicant | Ortho Diagnostic Systems, Inc., Carpinteria CA, US |
| Decision | Substantially Equivalent, Jul 14, 1982 |
| Received | Mar 8, 1982 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K820643
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.