510(k) K012521 ยท GTZ Antisera, All Groups, Streptococcus Spp.
BINAX NOW STREPTOCOCCUS PNEUMONIAE TEST
| Applicant | Binax, Inc., Portland ME, US |
| Decision | Substantially Equivalent, Nov 30, 2001 |
| Received | Aug 6, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012521
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 19, 2024 | Cypress Medical Products LLC BinaxNOW Respiratory Strep A Test Kit, CLIA Waived, Catalog Number 730025 Open, Classified |
GTZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.