510(k) K844399 ยท GTZ Antisera, All Groups, Streptococcus Spp.
RESPIRALEX LATEX AGGLUTINATION TEST
| Applicant | Orion Diagnostica, Inc., Somerset NJ, US |
| Decision | Substantially Equivalent, Jan 8, 1985 |
| Received | Nov 13, 1984 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K844399
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.