510(k) K954257 ยท GTZ Antisera, All Groups, Streptococcus Spp.
QUICKVUE IN-LINE ONE STEP STREP A TEST (MODIFICATION)
| Applicant | Quidel Corp., San Diego CA, US |
| Decision | Substantially Equivalent, Oct 20, 1995 |
| Received | Jul 27, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K954257
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.