510(k) K042884— DAKOCYTOMATION ER/PR PHARMDX KIT

Substantially Equivalent

Dakocytomation California, Inc.

Clearance details

Applicant: Dakocytomation California, Inc.
Product code: Code MXZ
Advisory panel: Hematology
Date received: 2004-10-19
Decision date: 2005-02-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carpinteria, CA, US

Download summary PDF View on FDA.gov ↗

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