FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BD Respiratory Viral Panel for BD MAX System; BD Respiratory Viral Panel-SCV2 for BD MAX System
K Number: K230956
·
Decision Jul 31, 2023
Classifications
1
FEI Numbers
32
Registration Numbers
32
Same Product Code
32
Applicant Total
1
Review Days
118
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Basic Information
- Device Name
- BD Respiratory Viral Panel for BD MAX System; BD Respiratory Viral Panel-SCV2 for BD MAX System
- K Number
- K230956
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3981
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bd Integrated Diagnostic Solutions /
- Date Received
- April 4, 2023
- Decision Date
- July 31, 2023
- Product Code
- QOF
- 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 |
|---|---|---|---|
| QOF | Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents | FDA class 2 | Microbiology |
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