Alere i Instrument, Alere i Influenza A & B, Alere i Strep A— 510(k) K151690

Substantially Equivalent

Alere Scarborough, Inc.

FDA 510(k) clearance K151690 for Alere i Instrument, Alere i Influenza A & B, Alere i Strep A, Substantially Equivalent on 2015-07-16. Applicant: Alere Scarborough, Inc..

Clearance details

Applicant: Alere Scarborough, Inc.
Product code: Code OOI
Advisory panel: Clinical Chemistry
Date received: 2015-06-23
Decision date: 2015-07-16
Decision: Substantially Equivalent
Clearance type: Special
Location: Scarborough, ME, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code OOI

product code OOI

Malfunction: 2,506
Other: 3
Total: 2,509

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.