FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CLEARVIEW EXACT II INFLUENZA A & B TEST
K Number: K103610
·
Decision Jan 6, 2011
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
71
Applicant Total
4
Review Days
28
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Basic Information
- Device Name
- CLEARVIEW EXACT II INFLUENZA A & B TEST
- K Number
- K103610
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 866.3328
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Alere Scarborough, Inc D/B/A Binax, Inc.
- Date Received
- December 9, 2010
- Decision Date
- January 6, 2011
- Product Code
- PSZ
- 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 |
|---|---|---|---|
| PSZ | Devices Detecting Influenza A, B, And C Virus Antigens | FDA class 2 | Microbiology |
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