DeviceClearance

K131776

Substantially Equivalent

ALDOLASE CONTROLS LEVEL 2, AND ALDOLASE CONTROL LEVEL 3

Applicant
Randox Laboratories, Ltd.
Product code
JJX
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Crumlin, GB
Download summary PDF View on FDA.gov ↗

Adverse events under product code JJX

product code JJX
Other
2
Total
2

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.