D-10 HEMOGLOBIN A1C PROGRAM - D-10 Hemoglobin A1C Program

• • Terminated Z-0695-2016 FDA Class II ·initiated 15 Dec 2015

  On a rare occasion, there is a potential to assign a patient result to an incorrect sample ID when running in D10 Rack Loader configuration.

510(k) Number

K060001 ↗

FDA Product Code

LCP

Models / Variants

D-10 Hemoglobin A1C Program

D-10 Dual Program

Device Class

Class II

Regulation

21 CFR Part 864.7470

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

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  Class II

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