FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
BD MAX Vaginal Panel
K Number: K191957
·
Decision Oct 21, 2019
Classifications
1
FEI Numbers
7
Registration Numbers
7
Same Product Code
10
Applicant Total
4
Review Days
90
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Basic Information
- Device Name
- BD MAX Vaginal Panel
- K Number
- K191957
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3975
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Geneohm Sciences Canada, Inc. (Bd Diagnostics)
- Date Received
- July 23, 2019
- Decision Date
- October 21, 2019
- 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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