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HEMOGLOBIN A1C, HEMOGLOBIN A1C CALIBRATORS, HEMOGLOBIN A1C CONTROLS — Abbott Laboratories (510(k) K130255)

HEMOGLOBIN A1C, HEMOGLOBIN A1C CALIBRATORS, HEMOGLOBIN A1C CONTROLS — Abbott Laboratories (510(k) K130255) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: HEMOGLOBIN A1C, HEMOGLOBIN A1C CALIBRATORS, HEMOGLOBIN A1C CONTROLS; Applicant: Abbott Laboratories; Clearance track: 510(k)

Device nameHEMOGLOBIN A1C, HEMOGLOBIN A1C CALIBRATORS, HEMOGLOBIN A1C CONTROLS
ApplicantAbbott Laboratories
Clearance track510(k)
Submission numberK130255
DecisionSubstantially Equivalent
Decision date2014-02-28
Date received2013-02-01
Product codePDJ
Device class2
Medical specialtyClinical Chemistry
Applicant locationIL, US
SourceopenFDA device

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