BINAXNOW PBP2A TEST, MODEL 890-000— 510(k) K090301
Substantially EquivalentBinax, Inc.
FDA 510(k) clearance K090301 for BINAXNOW PBP2A TEST, MODEL 890-000, Substantially Equivalent on 2010-04-14. Applicant: Binax, Inc..
Clearance details
- Applicant
- Binax, Inc.
- Product code
- Code MYI
- 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.