Simplexa C. auris Direct, Simplexa C. auris Positive Control Pack, Simplexa C. auris Sample Prep Kit (MOL3950, MOL3960, MOL5390)— 510(k) DEN230092
UnknownDiasorin Molecular, LLC
FDA 510(k) clearance DEN230092 for Simplexa C. auris Direct, Simplexa C. auris Positive Control Pack, Simplexa C. auris Sample Prep Kit (MOL3950, MOL3960, MOL5390), Unknown on 2024-07-15. Applicant: Diasorin Molecular, LLC. Device class: 2.
Clearance details
- Applicant
- Diasorin Molecular, LLC
- Product code
- Code SBT
- Device class
- Class 2
- Regulation
- 21 CFR 866.3967
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Unknown
- Clearance type
- Direct
- Location
- Cypress, CA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.