Simplexa Flu A/B & RSV Direct Gen II, Simplexa Flu A/B & RSV Positive Control Pack— 510(k) K201505
Substantially EquivalentDiasorin Molecular, LLC
FDA 510(k) clearance K201505 for Simplexa Flu A/B & RSV Direct Gen II, Simplexa Flu A/B & RSV Positive Control Pack, Substantially Equivalent on 2020-08-22. Applicant: Diasorin Molecular, LLC.
Clearance details
- Applicant
- Diasorin Molecular, LLC
- Product code
- Code OCC
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cypress, CA, US
Adverse events under product code OCC
product code OCC- Death
- 3
- Malfunction
- 706
- Total
- 709
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.