Home / 510(k) Clearances / K954420

510(k) K954420

AXSYM DIGITOXIN by Abbott Laboratories — Product Code LFM

K954420 is an FDA 510(k) premarket notification submitted by Abbott Laboratories for the device "AXSYM DIGITOXIN". The FDA issued a decision of Substantially Equivalent on December 29, 1995. The device falls under product code LFM (Enzyme Immunoassay, Digitoxin), a Class II device regulated under 21 CFR 862.3300. Abbott Laboratories has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 29, 1995
Date Received
September 21, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Digitoxin
Device Class
Class II
Regulation Number
862.3300
Review Panel
TX
Submission Type

Other clearances by Abbott Laboratories

  • K252424 — Anti-HCV Next (April 28, 2026)
  • K243500 — ARCHITECT iGentamicin (July 9, 2025)
  • K243168 — Alinity i Rubella IgG (June 20, 2025)
  • K243283 — Alinity h-series System (February 20, 2025)
  • K233932 — Alinity i Toxo IgM (August 30, 2024)
  • K232669 — TBI (September 29, 2023)
  • K222850 — HAVAb IgG II (August 10, 2023)
  • K220031 — Alinity h-series System (August 4, 2023)
  • K220282 — i-STAT PTplus Cartridge with the i-STAT 1 System (July 14, 2023)
  • K230937 — Alinity i Total ß-hCG Reagent Kit, GLP systems Track (June 5, 2023)

Other clearances for product code LFM

  • K062024 — DIMENSION VISTA DIGITOXIN, DIGOXIN, GENTAMICIN, N-ACETYLPROCAINAMIDE, PHENYTOIN, (July 28, 2006)
  • K012112 — RANDOX DIGITOXIN (January 11, 2002)
  • K990251 — DGTX FLEX REAGENT CARTRIDGE, MODEL DF36 (March 31, 1999)
  • K970546 — ACS DIGITOXIN (July 14, 1997)
  • K963158 — ABBOTT AXSYM DIGITOXIN (MODIFY) (September 10, 1996)
  • K951631 — DIGOXIN ASSAY FOR THE TECCHNICON RA/OPERA SYSTEMS IN-VITRO DIAGNOSTIC SYSTEMS (June 9, 1995)
  • K943235 — IMMULITE DIGITOXIN (October 27, 1994)
  • K942610 — KODAK EXTACHEM CLINICAL CHEMISTRY SLIDE DIGOXIN (DGXN) (October 20, 1994)
  • K942619 — EMIT 2000 DIGOXIN ASSAY/CALIBRATORS (September 20, 1994)
  • K915465 — DIGITOXIN FPIA REAGENT SET (January 27, 1992)

FDA data resources