Panels › Hematology › Product code LJX · Class 1
Test, Urine Leukocyte
Regulation 864.7675
0510(k)s in 12 months (7 all time)
3recalls in 12 months (5 all time)
2recalls that name a 510(k)
Top companies in LJX
| Company | 510(k)s | Recalls |
|---|---|---|
| Miles Laboratories, Inc. | 2 | 0 |
| ACON Laboratories, Inc. | 1 | 0 |
| ARKRAY USA INC. | 0 | 1 |
| Beckman Coulter Inc. | 0 | 1 |
| Changchun Wancheng Bio-Electron Co., Ltd. | 0 | 1 |
| Chronimed, Inc. | 1 | 0 |
| DFI Co., Ltd. | 0 | 1 |
| Dia-Screen Corp. | 1 | 0 |
| GET TESTED INTERNATIONAL AB | 0 | 1 |
| Healgen Scientific,, LLC | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 6, 2026 | DFI Co., Ltd. One Step UTI in vitro diagnostic test
REF: 3374 Open, Classified |
LJX | None listed |
| Feb 4, 2026 | Changchun Wancheng Bio-Electron Co., Ltd. LotFancy Urinary Tract Infection Urine (UTI) Test Strips;
PALINOIA UTI-10 PARAMETER REAGENT STRIPS;
Vaunn Medical 8-in-1 Urinalysis Reagent Strip;
JNW Direct 4-in-1 UTl Urinalysis Test Strips;
Urinify Open, Classified |
LJX | None listed |
| Dec 1, 2025 | GET TESTED INTERNATIONAL AB Urinary Tract Infection Test Open, Classified |
LJX | None listed |
| Dec 4, 2017 | Beckman Coulter Inc. iChem VELOCITY Urine Chemistry Strips, REF 800-7212
Product Usage:
The iChem VELOCITY automated urine chemistry system is an in vitro diagnostic deice used to automate the urine chemistry analysis pr Terminated |
LJX | K101852 |
| Sep 30, 2010 | ARKRAY USA INC. Hypoguard, DiaScreen 4pH, Reagent Strips for Urinalysis, 100 strips, Cat. No. D11400. Terminated |
LJX | K981555 |
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