Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit— 510(k) K173502
Substantially EquivalentAlere Scarborough, Inc.
FDA 510(k) clearance K173502 for Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit, Substantially Equivalent on 2017-12-13. Applicant: Alere Scarborough, Inc.. Device class: 2.
Clearance details
- Applicant
- Alere Scarborough, Inc.
- Product code
- Code PSZ
- Device class
- Class 2
- Regulation
- 21 CFR 866.3328
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Scarborough, ME, US
Recent devices under product code PSZ
view allMore clearances from Alere Scarborough, Inc.
view all- DEN180014 — WOUNDCHEK Bacterial Status
- K190204 — ID NOW Influenza A & B 2
- 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.