510(k) K982373 ยท GTY Antigens, All Groups, Streptococcus Spp.
UNI-GOLD STREP A TEST KIT
| Applicant | Trinity Biotech, Plc, Los Angeles CA, US |
| Decision | Substantially Equivalent, Feb 11, 1999 |
| Received | Jul 7, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K982373
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.