KJRClass I

Erythrosin B

21 CFR 864.1850 / Hematology

KJR is the FDA product code for Erythrosin B, a class I device type, regulated under 21 CFR 864.1850. As of 2026-09-10, FDA records hold 3 510(k) clearances under this code, the most recent dated 1984-08-28, and no recalls.

Classification record

Product code: KJR
Device name: Erythrosin B
Regulation: 21 CFR 864.1850
Device class: Class I
Review panel: Hematology
Submission type: 510(k) exempt
Implant: No
Life sustaining or supporting: No
GMP exempt: Yes
Third party review eligible: No
Ingested clearances: 3
Ingested recalls: 0

Clearances, product code KJR

By decision year

3 clearances under product code KJR with a decision year between 1979 and 1984, 1984 the highest year at 2.

Show the numbers

510(k) clearances under FDA product code KJR by decision year
Year	Clearances
1979	1
1984	2

Applicants with the most clearances

Product code KJR

Applicants holding the most 510(k) clearances under product code KJR
Applicant	Clearances
Bartels Immunodiagnostic Supplies, Inc.	2
Alta Diagnostics, Inc.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

Recent clearances

Product code KJR

Recent recalls

Product code KJR

FDA records show no recalls under product code KJR.

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)