Simplexa™ COVID-19/ Flu A/B & RSV Direct (MOL4450); Simplexa™ COVID-19/ Flu A/B & RSV Positive Control Pack (MOL4460)
FDA 510(k) clearance K252387 · decided 2025-10-30
Clearance details
- K-number
- K252387
- Device name
- Simplexa™ COVID-19/ Flu A/B & RSV Direct (MOL4450); Simplexa™ COVID-19/ Flu A/B & RSV Positive Control Pack (MOL4460)
- Applicant
- Diasorin Molecular, LLC
- Decision
- Substantially Equivalent
- Date received
- 2025-07-31
- Decision date
- 2025-10-30
- Days to decision
- 91 days
- Clearance type
- Traditional
- Product code
- QOF
- Device class
- 2
- Regulation number
- 866.3981
- 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.