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HemosIL AcuStar HIT-IgG(PF4-H), HemosIL AcuStar HIT Controls — Instrumentation Laboratory CO (510(k) K170854)

HemosIL AcuStar HIT-IgG(PF4-H), HemosIL AcuStar HIT Controls — Instrumentation Laboratory CO (510(k) K170854) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: HemosIL AcuStar HIT-IgG(PF4-H), HemosIL AcuStar HIT Controls; Applicant: Instrumentation Laboratory CO; Clearance track:

Device nameHemosIL AcuStar HIT-IgG(PF4-H), HemosIL AcuStar HIT Controls
ApplicantInstrumentation Laboratory CO
Clearance track510(k)
Submission numberK170854
DecisionSubstantially Equivalent
Decision date2017-09-08
Date received2017-03-22
Product codeLCO
Device class2
Medical specialtyHematology
Applicant locationMA, US
SourceopenFDA device

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