K100321

Substantially Equivalent

DIMENSION VISTA LOCI CA 125 FLEX REAGENT CARTRIDGE,AND DIMENSIONS VISTA LOCI 6 CAL, MODEL#'S K6455, AND KC604

Applicant: Siemens Healthcare Diagnostics
Product code: LTK
Advisory panel: Immunology
Date received: 2010-02-04
Decision date: 2011-04-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Newark, DE, US

Download summary PDF View on FDA.gov ↗

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