Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
LJX — Predicate Candidate Screening
7 FDA 510(k) clearances under this product code; the 50 most recent screened below.
65 daysmedian FDA review time
345 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K231045 | Healgen URS Test Strips | Healgen Scientific,, LLC | 2023-06-16 | 65 | 0 |
| K063295 | ACON UTI URINARY TRACT INFECTION TEST STRIPS | ACON Laboratories, Inc. | 2007-10-12 | 345 | 0 |
| K000578 | SERIM LEUKOCYTE ESTERASE TEST STRIPS | Serim Research Corp. | 2000-05-05 | 73 | 0 |
| K981555 | DIASCREEN REAGENT STRIPS | Chronimed, Inc. | 1998-06-01 | 31 | 1 |
| K971976 | DIASCREEN REAGENT STRIPS | Dia-Screen Corp. | 1997-06-17 | 19 | 0 |
| K873304 | CLINITEK AUTO 2000 REAGENT CASSETTE (LEUKOCYTES) | Miles Laboratories, Inc. | 1987-09-11 | 24 | 0 |
| K843727 | LEUKOSTIX REAGENT STRIPS FOR URINALYSIS | Miles Laboratories, Inc. | 1985-01-04 | 102 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda