DeviceClearance

K012820

Substantially Equivalent

AIA-PACK CTNI 2ND-GEN ASSAY

Applicant
Tosoh Medics, Inc.
Product code
MMI
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
South San Francisco, CA, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code MMI

product code MMI
Injury
172
Malfunction
3,762
Total
3,934

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.