Product code LFM— Clinical Toxicology
ABBOTT AXSYM DIGITOXIN (MODIFY)
- Classification name
- Enzyme Immunoassay, Digitoxin
- Device class
- Class 2
- Regulation
- 21 CFR 862.3300
- Advisory panel
- Clinical Toxicology
- Total cleared
- 20
- First cleared
- Most recent
Market context for product code LFM
FDA has cleared devices under product code LFM between 1983 and 2006, filed by 14 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2006
- 2002
- 1999
- 1997
- 1996
- 1995
- 1994
- 1992
- 1991
- 1990
- 1989
- 1986
- 1984
- 1983
Top applicants under product code LFM
Recent clearances under product code LFM
- K062024 — DIMENSION VISTA DIGITOXIN, DIGOXIN, GENTAMICIN, N-ACETYLPROCAINAMIDE, PHENYTOIN, THEOPHYLLINE FLEX REAGENT CARTRIDGE
- K012112 — RANDOX DIGITOXIN
- K990251 — DGTX FLEX REAGENT CARTRIDGE, MODEL DF36
- K970546 — ACS DIGITOXIN
- K963158 — ABBOTT AXSYM DIGITOXIN (MODIFY)
- K954420 — AXSYM DIGITOXIN
- K951631 — DIGOXIN ASSAY FOR THE TECCHNICON RA/OPERA SYSTEMS IN-VITRO DIAGNOSTIC SYSTEMS
- K943235 — IMMULITE DIGITOXIN
- K942610 — KODAK EXTACHEM CLINICAL CHEMISTRY SLIDE DIGOXIN (DGXN)
- K942619 — EMIT 2000 DIGOXIN ASSAY/CALIBRATORS
- K915465 — DIGITOXIN FPIA REAGENT SET
- K913187 — INNOFLUOR(TM) DIGITOXIN REAGENT SET
- K913240 — DIGITOXIN (FPIA) KIT
- K900013 — MILENIA (TM) DIGITOXIN
- K896021 — CEDIA DIGITOXIN ASSAY
- K891094 — ACA(R) DIGITOXIN (DGTX) METHOD
- K862067 — STRATUS DIGITOXIN FLUOROMETRIC ENZYME IMMUNOASSAY
- K842280 — TDX DIGITOXIN
- K842578 — SOPHEIA/MP DIGITOXIN EIA KIT
- K830035 — SOPHEIA DIGITOXIN EIA KIT & COMPONENTS
Data sourced from openFDA. This site is unofficial and independent of the FDA.