Vitros Chemistry Products D%A1C Reagent Kit, Model 680 2314; Vitros Chemistry Products Calibrator Kit 18, Model 680 1702

No FDA recalls found in the data synced 23 Oct 2026.

510(k) Number

K060650 ↗

FDA Product Code

LCP

Models / Variants

Vitros Chemistry Products D%A1C Reagent Kit, Model 680 2314

Vitros Chemistry Products Calibrator Kit 18, Model 680 1702

Device Class

Class II

Regulation

21 CFR Part 864.7470

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

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