Product Code: JRB FDA class 1 21 CFR 862.2050

Micro Mixer

Clinical Chemistry

The Micro Mixer is a small clinical laboratory instrument used to mix very small volumes of biological specimens or reagents rapidly and uniformly, ensuring homogeneous sample preparation and reaction conditions for clinical chemistry and other laboratory assays. This device is FDA Class 1, the lowest risk category, requiring only general controls and no premarket notification. It carries product code JRB 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
8
Registration Numbers
8
Unique Applicants
0
Years Active

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Basic Information

Product Code
JRB
Device Class
FDA class 1
Regulation Number
862.2050
Medical Specialty
Clinical Chemistry
Review Panel
CH
Submission Type
4

Device Characteristics

GMP Exempt
Implant
Life Sustain/Support
Third Party
Summary Malfunction Reporting

FEI Numbers

This FDA classification entry is associated with 8 FEI numbers. Click on an entry to view related FDA registrations.

Registration Numbers

This FDA classification entry is associated with 8 registration numbers. Click on an entry to view related FDA registrations.