Simplexa Flu A/B & RSV Direct and Simplexa Flu A/B & RSV Positive Control Pack— 510(k) K152408

Substantially Equivalent

Focus Diagnostics, Inc.

FDA 510(k) clearance K152408 for Simplexa Flu A/B & RSV Direct and Simplexa Flu A/B & RSV Positive Control Pack, Substantially Equivalent on 2015-09-21. Applicant: Focus Diagnostics, Inc..

Clearance details

Applicant: Focus Diagnostics, Inc.
Product code: Code OCC
Advisory panel: Microbiology
Date received: 2015-08-25
Decision date: 2015-09-21
Decision: Substantially Equivalent
Clearance type: Special
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.