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ABL837 FLEX ANALYZER — Radiometer Medical Aps (510(k) K100777)

ABL837 FLEX ANALYZER — Radiometer Medical Aps (510(k) K100777) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: ABL837 FLEX ANALYZER; Applicant: Radiometer Medical Aps; Clearance track: 510(k).

Device nameABL837 FLEX ANALYZER
ApplicantRadiometer Medical Aps
Clearance track510(k)
Submission numberK100777
DecisionSubstantially Equivalent
Decision date2010-12-10
Date received2010-03-18
Product codeCHL
Device class2
Medical specialtyClinical Chemistry
Applicant locationDK
SourceopenFDA device

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