QUIDEL MOLECULAR INFLUENZA A+B— 510(k) K113777
Substantially EquivalentQuidel Corp.
FDA 510(k) clearance K113777 for QUIDEL MOLECULAR INFLUENZA A+B, Substantially Equivalent on 2012-03-15. Applicant: Quidel Corp.. Device class: 2.
Clearance details
- Applicant
- Quidel Corp.
- Product code
- Product code OZE
- Device class
- Class 2
- Regulation
- 21 CFR 866.3980
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Diego, CA, US
Recent devices under product code OZE
view all- K263035 — CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel (includes Influenza A/B Typing Kit, Influenza A Subtyping Kit, Influenza A(H5) Subtyping Kit, and Influenza B Lineage Genotyping Kit)
- K243274 — CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit (VER 2) +3 more
- K243931 — CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit (VER 2) +3 more
- K241110 — CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit (Ver4)
- K230236 — Lyra Influenza A+B Assay
More clearances from Quidel Corp.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.