510(k) DEN230092
- Device
- Simplexa C. auris Direct, Simplexa C. auris Positive Control Pack, Simplexa C. auris Sample Prep Kit (MOL3950, MOL3960, MOL5390)
- Applicant
- Diasorin Molecular, LLC
- 510(k) number
- DEN230092
- Product code
- SBT
- Decision
- Unknown (DENG)
- Decision date
- 2024-07-15
- Date received
- 2023-12-28
- Regulation
- 866.3967
- Classification name
- Device To Detect Microbial Colonization Directly From Clinical Specimens.
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Michele Chwedoruk
- Address
- 11331 Valley View St. Cypress CA US 90630 90630
FDA Registration Numbers#
- 2023365
Source Documents#
510(k) summary PDF not indicated by FDA