K081731

Substantially Equivalent

DIMENSION CKI FLEX REAGENT CARTRIDGE, DIMENSION MBI FLEX REAGENT CARTRIDGE, AND CKI/MBI CALIBRATOR, MODELS DF38, DF32

Applicant: Siemens Healthcare Diagnostics
Product code: CGS
Advisory panel: Clinical Chemistry
Date received: 2008-06-19
Decision date: 2008-08-29
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.