LJX
7 FDA 510(k) clearances · Product code
65 daysmedian time to decision
345 days90th percentile
7clearances measured
FDA profile
- Official device name
- Test, Urine Leukocyte
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 864.7675
- Medical specialty
- Hematology
- Adverse events (MAUDE)
- 2012: 7
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Healgen URS Test Strips (K231045) | Healgen Scientific,, LLC | 2023-06-16 |
| ACON UTI URINARY TRACT INFECTION TEST STRIPS (K063295) | ACON Laboratories, Inc. | 2007-10-12 |
| SERIM LEUKOCYTE ESTERASE TEST STRIPS (K000578) | Serim Research Corp. | 2000-05-05 |
| DIASCREEN REAGENT STRIPS (K981555) | Chronimed, Inc. | 1998-06-01 |
| DIASCREEN REAGENT STRIPS (K971976) | Dia-Screen Corp. | 1997-06-17 |
| CLINITEK AUTO 2000 REAGENT CASSETTE (LEUKOCYTES) (K873304) | Miles Laboratories, Inc. | 1987-09-11 |
| LEUKOSTIX REAGENT STRIPS FOR URINALYSIS (K843727) | Miles Laboratories, Inc. | 1985-01-04 |
Track LJX automatically
Every clearance here is in the API, with alerts when new ones post.