Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
LFM — Predicate Candidate Screening
20 FDA 510(k) clearances under this product code; the 50 most recent screened below.
63 daysmedian FDA review time
152 days90th percentile
20clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K062024 | DIMENSION VISTA DIGITOXIN, DIGOXIN, GENTAMICIN, N-ACETYLPROC | Dade Behring, Inc. | 2006-07-28 | 10 | 2 |
| K012112 | RANDOX DIGITOXIN | Randox Laboratories, Ltd. | 2002-01-11 | 189 | 0 |
| K990251 | DGTX FLEX REAGENT CARTRIDGE, MODEL DF36 | Dade Behring, Inc. | 1999-03-31 | 63 | 0 |
| K970546 | ACS DIGITOXIN | Chiron Diagnostics Corp. | 1997-07-14 | 152 | 1 |
| K963158 | ABBOTT AXSYM DIGITOXIN (MODIFY) | Abbott Laboratories | 1996-09-10 | 46 | 0 |
| K954420 | AXSYM DIGITOXIN | Abbott Laboratories | 1995-12-29 | 99 | 0 |
| K951631 | DIGOXIN ASSAY FOR THE TECCHNICON RA/OPERA SYSTEMS IN-VITRO D | Bayer Corp. | 1995-06-09 | 63 | 0 |
| K943235 | IMMULITE DIGITOXIN | Diagnostic Products Corp. | 1994-10-27 | 113 | 0 |
| K942610 | KODAK EXTACHEM CLINICAL CHEMISTRY SLIDE DIGOXIN (DGXN) | Eastman Kodak Company | 1994-10-20 | 140 | 4 |
| K942619 | EMIT 2000 DIGOXIN ASSAY/CALIBRATORS | Syva Co. | 1994-09-20 | 117 | 0 |
| K915465 | DIGITOXIN FPIA REAGENT SET | Sigma Diagnostics, Inc. | 1992-01-27 | 56 | 0 |
| K913187 | INNOFLUOR(TM) DIGITOXIN REAGENT SET | Intl. Bioclinical, Inc. | 1991-09-23 | 67 | 0 |
| K913240 | DIGITOXIN (FPIA) KIT | Tudor Laboratories, Inc. | 1991-09-06 | 46 | 0 |
| K900013 | MILENIA (TM) DIGITOXIN | Diagnostic Products Corp. | 1990-03-09 | 66 | 0 |
| K896021 | CEDIA DIGITOXIN ASSAY | Microgenics Corp. | 1989-11-08 | 23 | 0 |
| K891094 | ACA(R) DIGITOXIN (DGTX) METHOD | E.I. Dupont DE Nemours & Co., Inc. | 1989-04-26 | 55 | 0 |
| K862067 | STRATUS DIGITOXIN FLUOROMETRIC ENZYME IMMUNOASSAY | American Dade | 1986-06-16 | 17 | 0 |
| K842280 | TDX DIGITOXIN | Abbott Laboratories | 1984-08-16 | 69 | 0 |
| K842578 | SOPHEIA/MP DIGITOXIN EIA KIT | Diagnostic Products Corp. | 1984-08-12 | 40 | 0 |
| K830035 | SOPHEIA DIGITOXIN EIA KIT & COMPONENTS | Diagnostic Products Corp. | 1983-01-28 | 21 | 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