ID NOW Influenza A & B 2— 510(k) K190204
Substantially EquivalentAlere Scarborough, Inc.
FDA 510(k) clearance K190204 for ID NOW Influenza A & B 2, Substantially Equivalent on 2019-03-18. Applicant: Alere Scarborough, Inc.. Device class: 2.
Clearance details
- Applicant
- Alere Scarborough, 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
- Special
- Location
- Scarborough, ME, 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
More clearances from Alere Scarborough, Inc.
view all- DEN180014 — WOUNDCHEK Bacterial Status
- K181853 — Alere BinaxNOW Influenza A & B Card 2, Alere Reader
- K173653 — Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 Control Swab Kit
- K173932 — Alere i Influenza A & B, Alere i Strep A, Alere i RSV, Alere i Influenza A & B 2
- K173502 — Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit
Data sourced from openFDA. This site is unofficial and independent of the FDA.