Blender/Mixer
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.
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Basic Information
- Product Code
- JRO
- Device Class
- FDA class 1
- Regulation Number
- 862.2050
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 4
Device Characteristics
FEI Numbers
This FDA classification entry is associated with 15 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 15 registration numbers. Click on an entry to view related FDA registrations.