FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Simplexa Flu A/B & RSV Direct & Simplexa Flu A/B RSV Positive Control Pack
K Number: K142365
·
Decision Dec 5, 2014
Classifications
1
FEI Numbers
32
Registration Numbers
32
Same Product Code
78
Applicant Total
4
Review Days
102
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Basic Information
- Device Name
- Simplexa Flu A/B & RSV Direct & Simplexa Flu A/B RSV Positive Control Pack
- K Number
- K142365
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3980
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Focus Diagnostics
- Date Received
- August 25, 2014
- Decision Date
- December 5, 2014
- Product Code
- OCC
- 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 |
|---|---|---|---|
| OCC | Respiratory Virus Panel Nucleic Acid Assay System | FDA class 2 | Microbiology |
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