K120945

Substantially Equivalent

HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE ALT, HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE AST

Applicant: Hitachi Chemical Diagnostics, Inc.
Product code: CKA
Advisory panel: Clinical Chemistry
Date received: 2012-03-29
Decision date: 2013-06-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mountain View, CA, US

Download summary PDF View on FDA.gov ↗

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