K111753

Substantially Equivalent

HITACHI CLINICAL ANALYZER S TEST REAGENT CATRIDGE FOR: CHOLESTROL, HDL, LDL, AND TRIGLYCERIDE

Applicant: Hitachi Chemical Diagnostics, Inc.
Product code: CHH
Advisory panel: Clinical Chemistry
Date received: 2011-06-22
Decision date: 2011-12-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Los Angeles, CA, US

Download summary PDF View on FDA.gov ↗

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