BINAXNOW INFLUENZA A & B TEST— 510(k) K062109
Substantially EquivalentBinax, Inc.
FDA 510(k) clearance K062109 for BINAXNOW INFLUENZA A & B TEST, Substantially Equivalent on 2006-11-09. Applicant: Binax, Inc..
Clearance details
- Applicant
- Binax, 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.