K093848

Substantially Equivalent

PT-MULTI-CALIBRATOR, MODEL OPAT07

Applicant: Dade Behring, Inc.
Product code: GGN
Advisory panel: Hematology
Date received: 2009-12-16
Decision date: 2010-12-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Newark, DE, US

Download summary PDF View on FDA.gov ↗

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