K973274

Substantially Equivalent

ACCUCOLOR HIGH CALIBRATOR (A3089)

Applicant: Sigma Diagnostics, Inc.
Product code: GIZ
Advisory panel: Hematology
Date received: 1997-09-02
Decision date: 1997-10-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Louis, MO, US

Download summary PDF View on FDA.gov ↗

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