510(k) K013379 ยท GTY Antigens, All Groups, Streptococcus Spp.
SAS STREPALERT
| Applicant | Sa Scientific, Inc., San Antonio TX, US |
| Decision | Substantially Equivalent, Dec 12, 2001 |
| Received | Oct 12, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K013379
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.