DeviceClearance

K940577

Substantially Equivalent

GLUCOMETER ELITE LOW CONTROL

Applicant
Heraeus Kulzer, Inc.
Product code
JJX
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mishawaka, IN, US
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.