K940490

Substantially Equivalent

DV TEST AND DVV CONFIRM

Applicant: American Diagnostica, Inc.
Product code: GIR
Advisory panel: Hematology
Date received: 1994-02-03
Decision date: 1995-04-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Greenwich, CT, US

Download summary PDF View on FDA.gov ↗

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