JRBClass I

Micro Mixer

21 CFR 862.2050 / Clinical Chemistry

JRB is the FDA product code for Micro Mixer, a class I device type, regulated under 21 CFR 862.2050. As of 2026-09-10, FDA records hold no 510(k) clearances under this code and one recall.

Classification record

Product code: JRB
Device name: Micro Mixer
Regulation: 21 CFR 862.2050
Device class: Class I
Review panel: Clinical Chemistry
Submission type: 510(k) exempt
Implant: No
Life sustaining or supporting: No
GMP exempt: Yes
Third party review eligible: No
Ingested clearances: 0
Ingested recalls: 1

Companies listing this code with FDA

Companies whose registered establishments list this code

Recent clearances

Product code JRB

FDA records hold no clearances under product code JRB.

Recent recalls

Product code JRB

Z-0968-2014Class IIOrtho Clinical Diagnostics issued a product correction notification for VITROS Chemistry Mixing Cup Arrays utilized on VITROS 250...Ortho-Clinical Diagnostics / initiated 2013-10-10 / 6380 units (each unit contains 48 arrays with 10 microcups)

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)