510(k) K011709 ยท GTZ Antisera, All Groups, Streptococcus Spp.
UNI-GOLD STREP A TEST KIT
| Applicant | Trinity Biotech, Plc, Ballinasloe, IE |
| Decision | Substantially Equivalent, Nov 8, 2001 |
| Received | Jun 4, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K011709
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.