FDA-Device2014-09-17Class II
RADIANCE v. 2.4X, 2.5X and 2.6X Product Usage: RADIANCE is a data processing application for clinical use intended to monitor, collect, store, retrieve and process laboratory data. RADIANCE is also intended to control clinical analyzers providing laboratory data.
Radiometer America Inc
Sold states
Worldwide Distribution - US (nationwide) in the states of AZ, CA, MO, MS, TX and UT. and the countries of: Austrialia, Austria, France, UK, Italy, Japan, Spain, India, and the Netherlands.
Affected count
N/A
Manufactured in
810 Sharon Dr, N/A, Westlake, OH, United States
Products
RADIANCE v. 2.4X, 2.5X and 2.6X Product Usage: RADIANCE is a data processing application for clinical use intended to monitor, collect, store, retrieve and process laboratory data. RADIANCE is also intended to control clinical analyzers providing laboratory data.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2597-2014Don't want to check this manually?
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