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..
Clearance details
- Applicant
- Alere Scarborough, Inc D/B/A Binax, Inc.
- Product code
- Code GNX
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Scarborough, ME, US
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