K991070

Substantially Equivalent

COULTER Z2 ANALYZER

Applicant
Coulter Corp.
Product code
GKL
Advisory panel
Hematology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Hialeah, FL, US
Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.