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PATHFAST CTNI-II TEST, PATHFAST CTNI CALIBRATORS, PATHFAST SAMPLE DILUENT 2 — Mitsubishi Chemical Medience CO (510(k) K100130)

PATHFAST CTNI-II TEST, PATHFAST CTNI CALIBRATORS, PATHFAST SAMPLE DILUENT 2 — Mitsubishi Chemical Medience CO (510(k) K100130) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: PATHFAST CTNI-II TEST, PATHFAST CTNI CALIBRATORS, PATHFAST SAMPLE DILUENT 2; Applicant: Mitsubishi Chemi

Device namePATHFAST CTNI-II TEST, PATHFAST CTNI CALIBRATORS, PATHFAST SAMPLE DILUENT 2
ApplicantMitsubishi Chemical Medience CO
Clearance track510(k)
Submission numberK100130
DecisionSubstantially Equivalent
Decision date2011-05-16
Date received2010-01-19
Product codeMMI
Device class2
Medical specialtyClinical Chemistry
Applicant locationMD, US
SourceopenFDA device

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