Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Leeco Diagnostics, Inc. — Predicate Candidate Screening
49 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
36 daysmedian FDA review time
102 days90th percentile
49clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K895765 | LEECO PREVIEW(R) EBV (EIA) | Leeco Diagnostics, Inc. | 1989-10-31 | 35 | 0 |
| K894122 | LEECO VIS-DISK STREP-A (EIA) | Leeco Diagnostics, Inc. | 1989-08-15 | 64 | 0 |
| K891096 | VIS-DISK HCG (EIA) JPL-041M | Leeco Diagnostics, Inc. | 1989-06-16 | 106 | 0 |
| K891095 | VIS-DISK HCG (EIA) LYOPHILIZED JPL-044M | Leeco Diagnostics, Inc. | 1989-06-16 | 106 | 0 |
| K883269 | PRL-QUANT | Leeco Diagnostics, Inc. | 1988-09-13 | 41 | 0 |
| K880577 | CONCEP-7-BHCG | Leeco Diagnostics, Inc. | 1988-03-15 | 34 | 0 |
| K880069 | LEECO PREGNASTICK (EIA) CATALOG #003 | Leeco Diagnostics, Inc. | 1988-02-11 | 31 | 0 |
| K870259 | VIS-CUBE HCG (EIA) LYOPHILIZED JPL-044 | Leeco Diagnostics, Inc. | 1987-03-10 | 46 | 0 |
| K864170 | LEECO VIS-CUBE STREP A (EIA) | Leeco Diagnostics, Inc. | 1987-02-03 | 102 | 0 |
| K863999 | VIS-CUBE PREGNANCY HOME TEST,CAT. # JPL-042 | Leeco Diagnostics, Inc. | 1987-01-09 | 87 | 0 |
| K863933 | VIS-CUBE HCG (EIA) | Leeco Diagnostics, Inc. | 1986-12-15 | 68 | 0 |
| K861354 | RIGHT-DAY OVULATION HOME TEST | Leeco Diagnostics, Inc. | 1986-09-16 | 159 | 0 |
| K861703 | LEECO CONCEP-7-BHCG (EIA) II (MODIFIED) | Leeco Diagnostics, Inc. | 1986-07-29 | 85 | 0 |
| K860538 | RIGHT-DAY URINARY LH (EIA) | Leeco Diagnostics, Inc. | 1986-07-29 | 167 | 0 |
| K861945 | LEE-BEAD PROLACTIN (EIA) | Leeco Diagnostics, Inc. | 1986-06-13 | 24 | 0 |
| K860947 | LEECO-SCREEN, STREP A (EIA) | Leeco Diagnostics, Inc. | 1986-05-13 | 62 | 0 |
| K860003 | LEECO TESTOSTERONE DIAGNOSTIC KIT | Leeco Diagnostics, Inc. | 1986-03-17 | 74 | 0 |
| K854837 | LEE-BEAD BETA FSH (EIA) | Leeco Diagnostics, Inc. | 1986-01-13 | 41 | 0 |
| K854838 | LEE-BEAD BETA LH (EIA) | Leeco Diagnostics, Inc. | 1986-01-07 | 35 | 0 |
| K853977 | BETA-TSH-IRMA | Leeco Diagnostics, Inc. | 1985-10-22 | 26 | 0 |
| K850531 | LEECO CONCEP-7-BHCG EIA | Leeco Diagnostics, Inc. | 1985-04-02 | 50 | 0 |
| K850530 | LEECO CONCEP-7-BHCG IRMA | Leeco Diagnostics, Inc. | 1985-04-02 | 50 | 0 |
| K850201 | LEECO CONCEP-7-BHCG LEIAD II | Leeco Diagnostics, Inc. | 1985-03-04 | 45 | 0 |
| K850056 | LEECO PROGESTERONE-QUANT DIAGNOSTIC TEST KIT | Leeco Diagnostics, Inc. | 1985-02-06 | 29 | 0 |
| K844153 | CONCEP-7-BHCG (EIA) | Leeco Diagnostics, Inc. | 1984-12-14 | 51 | 0 |
| K843384 | LEECO CORTISOL-QUANT | Leeco Diagnostics, Inc. | 1984-09-28 | 31 | 0 |
| K834586 | LEECO E2 QUANT DIAG. TEST KIT | Leeco Diagnostics, Inc. | 1984-03-09 | 71 | 0 |
| K834348 | LEECO T3-QUANT DIAG. KIT | Leeco Diagnostics, Inc. | 1984-02-21 | 70 | 0 |
| K831208 | IGE-QUANT DIAGNOSTIC TEST KIT | Leeco Diagnostics, Inc. | 1983-05-09 | 25 | 0 |
| K830785 | LEECO DIG-QUANT DIAG. TEST KIT | Leeco Diagnostics, Inc. | 1983-04-08 | 28 | 0 |
| K830808 | LEECO T3-RIA DIAGNOSTIC KIT | Leeco Diagnostics, Inc. | 1983-04-08 | 25 | 0 |
| K830512 | LEECO TESTOSTERONE DIAGNOSTIC KIT | Leeco Diagnostics, Inc. | 1983-04-05 | 47 | 0 |
| K822575 | LEECO T3% DIAGNOSTIC KIT | Leeco Diagnostics, Inc. | 1982-09-30 | 36 | 0 |
| K822399 | LEECO T4 QUANT DIAGNOSTICS TEST KIT | Leeco Diagnostics, Inc. | 1982-09-13 | 34 | 0 |
| K820039 | LEECO PRL-QUANT DIAGNOSTIC TEST KIT | Leeco Diagnostics, Inc. | 1982-01-22 | 15 | 0 |
| K813392 | RADIOIMMUNOASSAY FOR HUMAN THYROID | Leeco Diagnostics, Inc. | 1981-12-22 | 19 | 0 |
| K813059 | LEECO TESTO-QUANT DIAG. KIT | Leeco Diagnostics, Inc. | 1981-11-16 | 17 | 0 |
| K812156 | CONCEP-7-BHCG | Leeco Diagnostics, Inc. | 1981-08-20 | 22 | 0 |
| K811880 | LEECO FERRITIN-QUANT DIAG. TEST KIT | Leeco Diagnostics, Inc. | 1981-07-16 | 15 | 0 |
| K810662 | LEECO LH-QUANT DIAGNOSTIC KIT | Leeco Diagnostics, Inc. | 1981-03-31 | 20 | 0 |
| K810663 | LEECO FSH-QUANT DIAGNOSTIC KIT | Leeco Diagnostics, Inc. | 1981-03-27 | 16 | 0 |
| K810232 | LEECO P.A.P. - QUANT DIAGNOSTIC KIT | Leeco Diagnostics, Inc. | 1981-02-10 | 14 | 0 |
| K803001 | LEECO TESTO-QUANT DIAGNOSTIC KIT | Leeco Diagnostics, Inc. | 1981-01-02 | 38 | 0 |
| K801289 | LEECO GLYCO-HEMOGLOBIN DIAG. TEST KIT | Leeco Diagnostics, Inc. | 1980-06-30 | 31 | 0 |
| K792652 | LEECO P.A.P. QUANT. DIAGNOSTIC KIT | Leeco Diagnostics, Inc. | 1980-01-16 | 26 | 0 |
| K792308 | CONCEP-7-BHCG | Leeco Diagnostics, Inc. | 1979-12-06 | 20 | 0 |
| K791103 | LEECO GLYCO-HEMOGLOBIN DIAGNOSTIC KIT | Leeco Diagnostics, Inc. | 1979-06-28 | 15 | 0 |
| K790397 | CONCEP-7-B-HCG | Leeco Diagnostics, Inc. | 1979-05-23 | 86 | 0 |
| K782159 | DIAGNOSTIC KIT, FERRITAB-FE-59 | Leeco Diagnostics, Inc. | 1979-02-01 | 41 | 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