K022977

Substantially Equivalent

STRATUS CS D-DIMER CALPAK CALIBRATOR, MODEL CDDMR-C

Applicant: Dade Behring, Inc.
Product code: DAP
Advisory panel: Hematology
Date received: 2002-09-06
Decision date: 2002-11-27
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.