510(k) K894122 ยท GTZ Antisera, All Groups, Streptococcus Spp.
LEECO VIS-DISK STREP-A (EIA)
| Applicant | Leeco Diagnostics, Inc., Southfield MI, US |
| Decision | Substantially Equivalent, Aug 15, 1989 |
| Received | Jun 12, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K894122
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.