FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BD DIRECTIGEN EZ FLU A + B
K Number: K042472
·
Decision Jul 7, 2005
Classifications
1
FEI Numbers
37
Registration Numbers
37
Same Product Code
70
Applicant Total
113
Review Days
300
Basic Information
- Device Name
- BD DIRECTIGEN EZ FLU A + B
- K Number
- K042472
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3328
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- BECTON, DICKINSON & CO.
- Date Received
- September 10, 2004
- Decision Date
- July 7, 2005
- 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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