K182078

Substantially Equivalent

MiniCollect K2E K2EDTA Tubes

Applicant
Greiner Bio-One Na, Inc.
Product code
JKA
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Monroe, NC, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code JKA

product code JKA
Injury
455
Malfunction
26,686
Other
4
Total
27,145

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.