Product Code: JRO FDA class 1 21 CFR 862.2050

Blender/Mixer

Clinical Chemistry

The Blender/Mixer is a clinical laboratory instrument used to blend, homogenize, or mix biological specimens, reagent preparations, or control materials to ensure uniform composition prior to analysis in clinical chemistry testing. This device is FDA Class 1, the lowest risk category, subject only to general controls with no premarket submission required. It carries product code JRO and is regulated under 21 CFR 862.2050, within the Clinical Chemistry medical specialty. This device is GMP exempt.

510(k)s
0
FEI Numbers
15
Registration Numbers
15
Unique Applicants
0
Years Active

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