Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit— 510(k) K162642
Substantially EquivalentAlere Scarborough, Inc.
FDA 510(k) clearance K162642 for Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit, Substantially Equivalent on 2017-04-10. Applicant: Alere Scarborough, Inc..
Clearance details
- Applicant
- Alere Scarborough, Inc.
- Product code
- Code PSZ
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Scarborough, ME, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.