Simplexa VZV Direct, Simplexa VZV Positive Control Pack— 510(k) K190219
Substantially EquivalentDiasorin Molecular, LLC
FDA 510(k) clearance K190219 for Simplexa VZV Direct, Simplexa VZV Positive Control Pack, Substantially Equivalent on 2019-05-13. Applicant: Diasorin Molecular, LLC.
Clearance details
- Applicant
- Diasorin Molecular, LLC
- Product code
- Code PLO
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cypress, CA, US
Adverse events under product code PLO
product code PLO- Death
- 5
- Total
- 5
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.