Thermo Scientific Oxoid Sulbactam/Durlobactam Disc (10/10 µg) SUD20— 510(k) K232276
Substantially EquivalentOxoid Limited (Part of Thermo Fisher Scientific)
FDA 510(k) clearance K232276 for Thermo Scientific Oxoid Sulbactam/Durlobactam Disc (10/10 µg) SUD20, Substantially Equivalent on 2023-10-06. 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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Data sourced from openFDA. This site is unofficial and independent of the FDA.