510(k) K864170 ยท GTZ Antisera, All Groups, Streptococcus Spp.
LEECO VIS-CUBE STREP A (EIA)
| Applicant | Leeco Diagnostics, Inc., Southfield MI, US |
| Decision | Substantially Equivalent, Feb 3, 1987 |
| Received | Oct 24, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K864170
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.