Simplexa C. auris Direct, Simplexa C. auris Positive Control Pack, Simplexa C. auris Sample Prep Kit (MOL3950, MOL3960, MOL5390)
FDA 510(k) clearance DEN230092 · decided 2024-07-15
Clearance details
- 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
- Decision
- Unknown
- Date received
- 2023-12-28
- Decision date
- 2024-07-15
- Days to decision
- 200 days
- Clearance type
- Direct
- Product code
- SBT
- Device class
- 2
- Regulation number
- 866.3967
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Cypress, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.