510(k) K890840 ยท GTZ Antisera, All Groups, Streptococcus Spp.
VISUWELL GROUP A STREPTOCOCCUS DETECTION KIT
| Applicant | Adi Diagnostics, Inc., Rexdale, Ontario, CA |
| Decision | Substantially Equivalent, Mar 27, 1989 |
| Received | Feb 21, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K890840
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.