FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TRU FLU
K Number: K133714
·
Decision Jan 3, 2014
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
71
Applicant Total
38
Review Days
29
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Basic Information
- Device Name
- TRU FLU
- K Number
- K133714
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 866.3328
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Meridian Bioscience, Inc.
- Date Received
- December 5, 2013
- Decision Date
- January 3, 2014
- 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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