510(k) K163266— Alere i Influenza A & B, Alere i Influenza A & B Control Swab Kit, Alere i Instrument

Substantially Equivalent

Alere Scarborough, Inc.

Clearance details

Applicant: Alere Scarborough, Inc.
Product code: Code OCC
Advisory panel: Microbiology
Date received: 2016-11-21
Decision date: 2016-12-21
Decision: Substantially Equivalent
Clearance type: Special
Location: Scarborough, ME, US

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.