K042479

Substantially Equivalent

VITROS CHEMISTRY PRODUCTS GENT, TOBRA & VANC REAGENTS; VITROS CHEMISTYR PRODUCTS CALIBRATOR KITS 11, 13 & 14; VITROS CHE

Applicant: Ortho-Clinical Diagnostics, Inc.
Product code: LCD
Advisory panel: Clinical Toxicology
Date received: 2004-09-13
Decision date: 2005-01-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rochester, NY, US

Download summary PDF View on FDA.gov ↗

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