FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BD Vaginal Panel
K Number: K223653
·
Decision Mar 6, 2023
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
10
Applicant Total
77
Review Days
90
Basic Information
- Device Name
- BD Vaginal Panel
- K Number
- K223653
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3975
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Becton, Dickinson and Company
- Date Received
- December 6, 2022
- Decision Date
- March 6, 2023
- Product Code
- PQA
- 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 |
|---|---|---|---|
| PQA | Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System | FDA class 2 | Microbiology |
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