510(k) K010523 ยท GTZ Antisera, All Groups, Streptococcus Spp.
MODIFICATION TO BINAX NOW STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TEST
| Applicant | Binax, Inc., Portland ME, US |
| Decision | Substantially Equivalent, Mar 15, 2001 |
| Received | Feb 22, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K010523
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.