510(k) K801507 ยท GOL Antigen, Ha (Including Ha Control), Rubella
ANTIGEN CONTROL CELLS
| Applicant | Ortho Diagnostics, Inc., Walker MI, US |
| Decision | Substantially Equivalent, Aug 20, 1980 |
| Received | Jun 30, 1980 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K801507
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.