Atlas FDA

LFM

20 FDA 510(k) clearances · Product code

63 daysmedian time to decision
152 days90th percentile
20clearances measured

FDA profile

Official device name
Enzyme Immunoassay, Digitoxin
Device class
Class II (moderate risk)
Regulation
21 CFR 862.3300
Medical specialty
Clinical Toxicology
Flags
Third-party review eligible
Adverse events (MAUDE)
2017: 11 · 2018: 25 · 2020: 29 · 2021: 25 · 2023: 27 · 2025: 18
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
DIMENSION VISTA DIGITOXIN, DIGOXIN, GENTAMICIN, N-ACETYLPROCAINAMIDE, PHENYTOIN, THEOPHYLLINE FLEX REAGENT CARTRIDGE (K062024)Dade Behring, Inc.2006-07-28
RANDOX DIGITOXIN (K012112)Randox Laboratories, Ltd.2002-01-11
DGTX FLEX REAGENT CARTRIDGE, MODEL DF36 (K990251)Dade Behring, Inc.1999-03-31
ACS DIGITOXIN (K970546)Chiron Diagnostics Corp.1997-07-14
ABBOTT AXSYM DIGITOXIN (MODIFY) (K963158)Abbott Laboratories1996-09-10
AXSYM DIGITOXIN (K954420)Abbott Laboratories1995-12-29
DIGOXIN ASSAY FOR THE TECCHNICON RA/OPERA SYSTEMS IN-VITRO DIAGNOSTIC SYSTEMS (K951631)Bayer Corp.1995-06-09
IMMULITE DIGITOXIN (K943235)Diagnostic Products Corp.1994-10-27
KODAK EXTACHEM CLINICAL CHEMISTRY SLIDE DIGOXIN (DGXN) (K942610)Eastman Kodak Company1994-10-20
EMIT 2000 DIGOXIN ASSAY/CALIBRATORS (K942619)Syva Co.1994-09-20
DIGITOXIN FPIA REAGENT SET (K915465)Sigma Diagnostics, Inc.1992-01-27
INNOFLUOR(TM) DIGITOXIN REAGENT SET (K913187)Intl. Bioclinical, Inc.1991-09-23
DIGITOXIN (FPIA) KIT (K913240)Tudor Laboratories, Inc.1991-09-06
MILENIA (TM) DIGITOXIN (K900013)Diagnostic Products Corp.1990-03-09
CEDIA DIGITOXIN ASSAY (K896021)Microgenics Corp.1989-11-08
ACA(R) DIGITOXIN (DGTX) METHOD (K891094)E.I. Dupont DE Nemours & Co., Inc.1989-04-26
STRATUS DIGITOXIN FLUOROMETRIC ENZYME IMMUNOASSAY (K862067)American Dade1986-06-16
TDX DIGITOXIN (K842280)Abbott Laboratories1984-08-16
SOPHEIA/MP DIGITOXIN EIA KIT (K842578)Diagnostic Products Corp.1984-08-12
SOPHEIA DIGITOXIN EIA KIT & COMPONENTS (K830035)Diagnostic Products Corp.1983-01-28

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Every clearance here is in the API, with alerts when new ones post.