K120609

Substantially Equivalent

VITROS CHEMISTRY PRODUCTS DHDL SLIDES

Applicant: Ortho-Clinical Diagnostics, Inc.
Product code: LBS
Advisory panel: Clinical Chemistry
Date received: 2012-02-29
Decision date: 2012-09-07
Decision: Substantially Equivalent
Clearance type: Special
Location: Rochester, NY, US

Download summary PDF View on FDA.gov ↗

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