US device clearances
30 510(k) clearances and PMA approvals since 2015
- Biofire Filmarray Gastrointestinal 1.1 (Gi1.1) Panel; Biofire Filmarray Gastroi… K262172 · 6 Nov 2026
- Biofire Spotfire Vaginitis (Vg) Panel K262136 · 21 Oct 2026
- Biofire Respiratory Panel 2.1 (Rp2.1) K263054 · 22 Sep 2026
- Biofire Spotfire Respiratory/Sore Throat Panel Mini K243544 · 14 Aug 2025
- Biofire Filmarray Gastrointestinal (Gi) Panel Mid K243885 · 16 Jan 2025
Source: FDA 510(k) and PMA databases, 510(k) clearances, and PMA approvals or changes, since 2015; newest shown. Retrieved 13 Nov 2026.