510(k) K091489 ยท GTY Antigens, All Groups, Streptococcus Spp.
CLEARVIEW ADVANCED STREP A , MODEL 737-430
| Applicant | Binax, Inc., Scarborough ME, US |
| Decision | Substantially Equivalent, Sep 4, 2009 |
| Received | May 20, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K091489
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.