FDA 510(k)
FDA class 2
Unknown
🇨🇦 Canada
BD MAX Vaginal Panel, BD MAX Instrument
K Number: DEN160001
·
Decision Oct 28, 2016
Classifications
1
FEI Numbers
7
Registration Numbers
7
Same Product Code
10
Applicant Total
4
Review Days
291
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Basic Information
- Device Name
- BD MAX Vaginal Panel, BD MAX Instrument
- K Number
- DEN160001
- Device Class
- FDA class 2
- Clearance Type
- Direct
- Regulation Number
- 866.3975
- Medical Specialty
- Microbiology
- Decision
- Unknown
- Applicant
- Geneohm Sciences Canada, Inc. (Bd Diagnostics)
- Date Received
- January 11, 2016
- Decision Date
- October 28, 2016
- 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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