510(k) K862475 ยท GTY Antigens, All Groups, Streptococcus Spp.
RESPIRASTICK ENZYME IMMUNOASSAY TEST
| Applicant | Orion Diagnostica, Inc., Somerset NJ, US |
| Decision | Substantially Equivalent, Sep 16, 1986 |
| Received | Jun 30, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K862475
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.