FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
MALDI Biotyper CA (MBT-CA) System, MBT smart CA System
K Number: K163536
·
Decision Jul 26, 2017
Classifications
1
FEI Numbers
5
Registration Numbers
5
Same Product Code
4
Applicant Total
3
Review Days
222
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Basic Information
- Device Name
- MALDI Biotyper CA (MBT-CA) System, MBT smart CA System
- K Number
- K163536
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3361
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bruker Daltonik GmbH
- Date Received
- December 16, 2016
- Decision Date
- July 26, 2017
- Product Code
- PEX
- 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 |
|---|---|---|---|
| PEX | System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates | FDA class 2 | Microbiology |
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