Simplexa Flu A/B & RSV Direct & Simplexa Flu A/B RSV Positive Control Pack— 510(k) K142365

Substantially Equivalent

Focus Diagnostics

FDA 510(k) clearance K142365 for Simplexa Flu A/B & RSV Direct & Simplexa Flu A/B RSV Positive Control Pack, Substantially Equivalent on 2014-12-05. Applicant: Focus Diagnostics.

Clearance details

Applicant: Focus Diagnostics
Product code: Code OCC
Advisory panel: Microbiology
Date received: 2014-08-25
Decision date: 2014-12-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cypress, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code OCC

product code OCC

Death: 3
Malfunction: 706
Total: 709

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.