FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ALERE BINAXNOW INFLUENZA A & B CARD
K Number: K133411
·
Decision Dec 5, 2013
Classifications
1
FEI Numbers
12
Registration Numbers
12
Same Product Code
17
Applicant Total
4
Review Days
28
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Basic Information
- Device Name
- ALERE BINAXNOW INFLUENZA A & B CARD
- K Number
- K133411
- Device Class
- FDA class 1
- Clearance Type
- Special
- Regulation Number
- 866.3330
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Alere Scarborough, Inc D/B/A Binax, Inc.
- Date Received
- November 7, 2013
- Decision Date
- December 5, 2013
- Product Code
- GNX
- Advisory Committee
- Microbiology
- Review Advisory Committee
- MI
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GNX | Antigens, Cf (Including Cf Control), Influenza Virus A, B, C | FDA class 1 | Microbiology |
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