FluChip-8G Influenza A+B Assay— 510(k) K182513
Substantially EquivalentIndevr, Inc.
FDA 510(k) clearance K182513 for FluChip-8G Influenza A+B Assay, Substantially Equivalent on 2019-04-22. Applicant: Indevr, Inc.. Device class: 2.
Clearance details
- Applicant
- Indevr, Inc.
- Product code
- 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
- Boulder, CO, US
Recent devices under product code OZE
view all- 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
- K220801 — ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2
Data sourced from openFDA. This site is unofficial and independent of the FDA.