510(k) K991726 ยท GTZ Antisera, All Groups, Streptococcus Spp.
BINAX NOWR STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TEST (22 TEST KIT),(12 TEST KIT), BINAX NOWR STREPTOCOCCUS PNEUMONI
| Applicant | Binax, Inc., Portland ME, US |
| Decision | Substantially Equivalent, Aug 27, 1999 |
| Received | May 20, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K991726
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.