MODIFICATION TO: BINAXNOW INFLUENZA A & B TEST— 510(k) K092223
Substantially EquivalentBinax, Inc.
FDA 510(k) clearance K092223 for MODIFICATION TO: BINAXNOW INFLUENZA A & B TEST, Substantially Equivalent on 2009-08-12. Applicant: Binax, Inc..
Clearance details
- Applicant
- Binax, Inc.
- Product code
- Code PSZ
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Scarborough, ME, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.