FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BD Kiestra IdentifA
K Number: K191964
·
Decision Nov 3, 2021
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
3
Applicant Total
77
Review Days
834
Basic Information
- Device Name
- BD Kiestra IdentifA
- K Number
- K191964
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3378
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Becton, Dickinson and Company
- Date Received
- July 23, 2019
- Decision Date
- November 3, 2021
- Product Code
- QQV
- 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 |
|---|---|---|---|
| QQV | Automated System For Sample Preparation And Identification Of Microorganisms From Cultured Isolates By Mass Spectrometry | FDA class 2 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (QQV), ordered by most recent decision date.
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