MALDI Biotyper CA System— 510(k) K142677
Substantially EquivalentBruker Daltonics, Inc.
FDA 510(k) clearance K142677 for MALDI Biotyper CA System, Substantially Equivalent on 2015-03-27. Applicant: Bruker Daltonics, Inc.. Device class: 2.
Clearance details
- Applicant
- Bruker Daltonics, Inc.
- Product code
- Code PEX
- Device class
- Class 2
- Regulation
- 21 CFR 866.3361
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Billerica, MA, US
Recent devices under product code PEX
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