FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FLU OIA A/B TEST KIT
K Number: K023556
·
Decision Mar 27, 2003
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
71
Applicant Total
5
Review Days
155
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Basic Information
- Device Name
- FLU OIA A/B TEST KIT
- K Number
- K023556
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3328
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Thermo Biostar, Inc.
- Date Received
- October 23, 2002
- Decision Date
- March 27, 2003
- 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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