Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
LHL — Predicate Candidate Screening
18 FDA 510(k) clearances under this product code; the 50 most recent screened below.
84 daysmedian FDA review time
187 days90th percentile
18clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K984123 | THE APTUS (AUTOMATED) APPLICATION OF THE LEGIONELLA IGG/A/M | Zeus Scientific, Inc. | 1999-01-11 | 54 | 0 |
| K970149 | LEGIONELLA ELISA TEST SYSTEM | Zeus Scientific, Inc. | 1997-06-18 | 154 | 1 |
| K963318 | LEGIONELLA IGG/IGM ELISA TEST SYSTEM | Armkel, LLC | 1997-03-03 | 192 | 0 |
| K921421 | LEGIONELLA REAGENS FOR DIRECT FLUORESCENT ANTIBODY | Pro-Lab, Inc. | 1992-07-28 | 126 | 0 |
| K871328 | DU PONT LEGIONELLA URINARY ANTIGEN - RIA KIT | E.I. Dupont DE Nemours & Co., Inc. | 1987-09-02 | 152 | 0 |
| K864006 | LEGIONELLA PNEUMOPHILA SER. 1 ANTIGEN LATEX TEST | Medical Diagnostic Technologies, Inc. | 1987-04-20 | 187 | 0 |
| K854108 | POLYVALENT FLUORESCENT ANTIBODY REAGENTS FOR LEGIO | Medical Diagnostic Technologies, Inc. | 1985-11-12 | 35 | 0 |
| K852237 | LEGIONELLA IMMUNOFLUORESCENT ANTIBODY TEST KIT | Genetic Systems Corp. | 1985-08-22 | 92 | 0 |
| K842683 | GENETIC SYS LEGIONELLA IMMUNOFLURORES | Genetic Systems Corp. | 1984-08-02 | 23 | 0 |
| K832896 | LEGIONELLA INDIRECT FLUORESCENT ANTIBOD | Biodan Medical Systems, Ltd. | 1983-10-14 | 52 | 0 |
| K831760 | LEGIONELLA IFA KIT I | Bionetic Laboratory Products | 1983-08-08 | 68 | 0 |
| K831026 | INDIRECT FLUORESCENT ANTIBODY REAGENTS | Zeus Technologies | 1983-06-22 | 84 | 0 |
| K830820 | LEGIONELLA DFA KIT I | Bionetic Laboratory Products | 1983-06-08 | 85 | 0 |
| K822859 | DIRECT FA CONJUGATE FOR LEGIONELLA SPP | Zeus Technologies | 1983-02-16 | 142 | 0 |
| K822066 | LEGIONELLA PNEUMOPHILA | Biodan Medical Systems, Ltd. | 1982-09-21 | 69 | 0 |
| K813339 | DIRECT FA CONJUGATE FOR LEGIONELLA SP | Springwood Microbiologicals | 1981-12-18 | 24 | 0 |
| K812007 | LEGIONELLA INDIRECT FLUOR. ANTIBODY | Centers for Disease Control and Prevention | 1981-09-08 | 54 | 0 |
| K812006 | LEGIONELLA DIRECT FLUORESCENT ANTIBODY | Centers for Disease Control and Prevention | 1981-09-08 | 54 | 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