DeviceClearance

K961142

Substantially Equivalent

STRATEC LIA II ANALYZER

Applicant
Nichols Institute Diagnostics
Product code
JJE
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
San Juan Capistrano, CA, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code JJE

product code JJE
Death
6
Injury
441
Malfunction
25,011
Other
1
Total
25,459

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.