DeviceClearance

K001993

Substantially Equivalent

SOF-TACT DIABETES MANAGEMENT SYSTEM; SOF-TACT GLUCOSE TEST STRIP; PRECISION CONTROL SOLUTIONS

Applicant
Abbott Laboratories
Product code
LFR
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Bedford, MA, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code LFR

product code LFR
Death
3
Malfunction
1,634
Total
1,637

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.