DEN230092
- 510(k) number
- DEN230092
- Device name
- Simplexa C. auris Direct, Simplexa C. auris Positive Control Pack, Simplexa C. auris Sample Prep Kit (MOL3950, MOL3960, MOL5390)
- Applicant
- Diasorin Molecular, LLC CA · US
- Product code
- SBT — Device To Detect Microbial Colonization Directly Fro
- Decision date
- 2024-07-15
- Date received
- 2023-12-28
- Decision
- Unknown
- Clearance type
- Direct
- Advisory committee
- Microbiology
Official FDA record: DEN230092
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.