ID NOW Influenza A & B 2— 510(k) K191534

Substantially Equivalent

Abbott Diagnostics Scarborough, Inc.

FDA 510(k) clearance K191534 for ID NOW Influenza A & B 2, Substantially Equivalent on 2019-07-11. Applicant: Abbott Diagnostics Scarborough, Inc..

Clearance details

Applicant: Abbott Diagnostics Scarborough, Inc.
Product code: Code OCC
Advisory panel: Microbiology
Date received: 2019-06-10
Decision date: 2019-07-11
Decision: Substantially Equivalent
Clearance type: Special
Location: Scarborough, ME, 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.