ALERE BINAXNOW INFLUENZA A & B CARD— 510(k) K133411
Substantially EquivalentAlere Scarborough, Inc D/B/A Binax, Inc.
FDA 510(k) clearance K133411 for ALERE BINAXNOW INFLUENZA A & B CARD, Substantially Equivalent on 2013-12-05. Applicant: Alere Scarborough, Inc D/B/A Binax, Inc.. Device class: 1.
Clearance details
- Applicant
- Alere Scarborough, Inc D/B/A Binax, Inc.
- Product code
- Code GNX
- Device class
- Class 1
- Regulation
- 21 CFR 866.3330
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Scarborough, ME, US
Recent devices under product code GNX
view allMore clearances from Alere Scarborough, Inc D/B/A Binax, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.