510(k) K962146 ยท GTZ Antisera, All Groups, Streptococcus Spp.
EXCEL ONESTEP GROUP A STREP ANTIGEN MODULE TEST KIT
| Applicant | Excel Scientific, Inc., Yorba Linda CA, US |
| Decision | Substantially Equivalent, Oct 7, 1996 |
| Received | Jun 3, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K962146
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.