FDA product code LJX: Test, Urine Leukocyte
LJX is the FDA product code for test, urine leukocyte. It is a Class I device, regulated under 21 CFR 864.7675 and reviewed by the Hematology panel. FDA has cleared 7 510(k) submissions under LJX, 1 in the last five years, from 6 different applicants. The average 510(k) review took 94 days (median 65). FDA has posted 5 recalls for LJX devices, 3 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Test, Urine Leukocyte |
| Device class | Class I |
| Regulation | 21 CFR 864.7675 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) exempt |
510(k) clearances per year for LJX
| Year | Clearances | Avg. review days |
|---|---|---|
| 2023 | 1 | 65 |
Compare with all 510(k) review times · Search every LJX clearance
Top LJX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Miles Laboratories, Inc. | 2 | 1987-09-11 |
| Healgen Scientific,, LLC | 1 | 2023-06-16 |
| ACON Laboratories, Inc. | 1 | 2007-10-12 |
| Serim Research Corp. | 1 | 2000-05-05 |
| Chronimed, Inc. | 1 | 1998-06-01 |
1 more applicants have LJX clearances. See the full list in Caduvo.
Most recent LJX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K231045 | Healgen Scientific,, LLC | Healgen URS Test Strips | 2023-06-16 | 65 |
| K063295 | ACON Laboratories, Inc. | ACON UTI URINARY TRACT INFECTION TEST STRIPS | 2007-10-12 | 345 |
| K000578 | Serim Research Corp. | SERIM LEUKOCYTE ESTERASE TEST STRIPS | 2000-05-05 | 73 |
| K981555 | Chronimed, Inc. | DIASCREEN REAGENT STRIPS | 1998-06-01 | 31 |
| K971976 | Dia-Screen Corp. | DIASCREEN REAGENT STRIPS | 1997-06-17 | 19 |
Recalls for LJX devices
5 product recalls in 5 recall events; 3 initiated in the last five years and 3 still open. Most recent: 2026-04-02.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2025 | 2 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code LJX?
LJX is the FDA product code for test, urine leukocyte. It is a Class I device, regulated under 21 CFR 864.7675 and reviewed by the Hematology panel.
What device class is LJX?
Class I, regulation 21 CFR 864.7675. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code LJX?
Across 7 cleared submissions the average was 94 days from receipt to decision (median 65).
Which companies have the most LJX clearances?
Miles Laboratories, Inc. (2); Healgen Scientific,, LLC (1); ACON Laboratories, Inc. (1); Serim Research Corp. (1); Chronimed, Inc. (1).
Have LJX devices been recalled?
Yes: 5 product recalls across 5 recall events; the most recent began 2026-04-02.
Next steps
- Run an FDA pathway report with predicate devices for product code LJX
- Run a recall and safety report across every LJX manufacturer
- Watch product code LJX for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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