LJXClass I

Test, Urine Leukocyte

21 CFR 864.7675 / Hematology

LJX is the FDA product code for Test, Urine Leukocyte, a class I device type, regulated under 21 CFR 864.7675. As of 2026-09-10, FDA records hold 7 510(k) clearances under this code, the most recent dated 2023-06-16, and 5 recalls.

Classification record

Product code: LJX
Device name: Test, Urine Leukocyte
Regulation: 21 CFR 864.7675
Device class: Class I
Review panel: Hematology
Submission type: 510(k) exempt
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 7
Ingested recalls: 5

Clearances, product code LJX

By decision year

7 clearances under product code LJX with a decision year between 1985 and 2023, 1985 the highest year at 1.

Show the numbers

510(k) clearances under FDA product code LJX by decision year
Year	Clearances
1985	1
1987	1
1997	1
1998	1
2000	1
2007	1
2023	1

Applicants with the most clearances

Product code LJX

Applicants holding the most 510(k) clearances under product code LJX
Applicant	Clearances
Miles Laboratories, Inc.	2
Acon Laboratories, Inc.	1
Chronimed, Inc.	1
Dia-Screen Corp.	1
Healgen Scientific LLC	1
Serim Research Corp.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 80 companies shown, in name order