510(k) K801876 ยท GTX Antisera, Fluorescent, All Groups, Streptococcus Spp.
STREP B POLYVALENT FLUORO-KIT
| Applicant | Clinical Sciences, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Sep 16, 1980 |
| Received | Aug 5, 1980 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K801876
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.