K943313

Substantially Equivalent

PHENYTOIN FPIA REAGENT SET AND CALIBRATORS

Applicant: Sigma Diagnostics, Inc.
Product code: LGR
Advisory panel: Clinical Toxicology
Date received: 1994-07-11
Decision date: 1994-10-27
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.