K061588

Substantially Equivalent

VITROS CHEMISTRY PRODUCTS HCY REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 27, HCY PERFORMANCE VERIFIERS

Applicant: Ortho-Clinical Diagnostics, Inc.
Product code: LPS
Advisory panel: Clinical Chemistry
Date received: 2006-06-08
Decision date: 2006-07-21
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.