510(k) K011097 ยท GTY Antigens, All Groups, Streptococcus Spp.
QUICKVUE DIPSTICK STREP A
| Applicant | Quidel Corp., San Diego CA, US |
| Decision | Substantially Equivalent, May 8, 2001 |
| Received | Apr 11, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K011097
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 12, 2026 | Quidel Corporation QuickVue Dipstick Strep A Test, 50T, REF 20108, antigens, all groups, streptococcus spp. Open, Classified |
GTY | None listed |
| Sep 10, 2025 | Quidel Corporation QuickVue: Dipstick Strep A Test: 50T, REF: 20108; 25T, REF: 20125; 50T, SCN, REF: 20108SC Open, Classified |
GTY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.