Thermo Scientific Oxoid Meropenem/Vaborbactam Disc (30µg) MEV30— 510(k) K181975
Substantially EquivalentOxoid Limited (Part of Thermo Fisher Scientific)
FDA 510(k) clearance K181975 for Thermo Scientific Oxoid Meropenem/Vaborbactam Disc (30µg) MEV30, Substantially Equivalent on 2018-09-27. Applicant: Oxoid Limited (Part of Thermo Fisher Scientific). Device class: 2.
Clearance details
- Applicant
- Oxoid Limited (Part of Thermo Fisher Scientific)
- Product code
- Code JTN
- Device class
- Class 2
- Regulation
- 21 CFR 866.1620
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Basingstoke, GB
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