HEMOCUE WBC SYSTEM— 510(k) K071652

Substantially Equivalent

Hemocue AB

FDA 510(k) clearance K071652 for HEMOCUE WBC SYSTEM, Substantially Equivalent on 2007-10-25. Applicant: Hemocue AB.

Clearance details

Applicant: Hemocue AB
Product code: Code GKL
Advisory panel: Hematology
Date received: 2007-06-18
Decision date: 2007-10-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lake Forest, CA, US

Download summary PDF View on FDA.gov ↗

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