K962435

Substantially Equivalent

STC AUTO-LYTE URINARY GLUCOSE ASSAY

Applicant: OraSure Technologies, Inc.
Product code: CFR
Advisory panel: Clinical Chemistry
Date received: 1996-06-24
Decision date: 1996-12-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bethlehem, PA, US

Download summary PDF View on FDA.gov ↗

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