DeviceClearance

K161375

Substantially Equivalent

Alere i RSV, Alere i Instrument, Alere i RSV Control Swab Kit

Applicant
Alere Scarborough, Inc.
Product code
OCC
Advisory panel
Microbiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
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, through . 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.