Home / 510(k) Clearances / K894521

510(k) K894521

FPR DIGOXIN KIT by Colony Laboratories, Inc. — Product Code KXT

K894521 is an FDA 510(k) premarket notification submitted by Colony Laboratories, Inc. for the device "FPR DIGOXIN KIT". The FDA issued a decision of Substantially Equivalent on September 25, 1989. The device falls under product code KXT (Enzyme Immunoassay, Digoxin), a Class II device regulated under 21 CFR 862.3320. Colony Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 25, 1989
Date Received
July 20, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Digoxin
Device Class
Class II
Regulation Number
862.3320
Review Panel
TX
Submission Type

Other clearances by Colony Laboratories, Inc.

  • K894518 — FPR AMIKACIN CALIBRATOR KIT (September 28, 1989)
  • K894517 — FPR AMIKACIN KIT (September 28, 1989)
  • K894524 — FPR GENTAMICIN CALIBRATOR KIT (September 28, 1989)
  • K894523 — FPR GENTAMICIN KIT (September 28, 1989)
  • K894528 — FPR PHENYTOIN CALIBRATOR KIT (September 25, 1989)
  • K894527 — FPR PHENYTOIN KIT (September 25, 1989)
  • K894522 — FPR DIGOXIN CALIBRATOR KIT (September 25, 1989)
  • K894530 — FPR THEOPHYLLINE CALIBRATOR KIT (September 18, 1989)
  • K894529 — FPR THEOPHYLLINE KIT (September 15, 1989)
  • K894532 — FPR TOBRAMYCIN CALIBRATOR KIT (September 1, 1989)

Other clearances for product code KXT

  • K193397 — ADVIA Centaur® Digoxin assay (July 16, 2021)
  • K153301 — Elecsys Digoxin Immunoassay, Elecsys PreciControl Cardiac II (April 8, 2016)
  • K102346 — RANDOX DIGOXIN ASSAY (October 14, 2011)
  • K093441 — DIMENSION VISTA LOCI DIGOXIN FLEX REAGENT CARTRIDGE (DIGXN), MODEL K6435 (April 7, 2010)
  • K082953 — ARCHITECT IDIGOXIN AND ARCHITECT IDIGOXIN CALIBRATORS, MODELS 1P32-25 AND IP32-0 (December 22, 2008)
  • K061249 — AXSYM DIGOXIN III (June 2, 2006)
  • K033007 — BAYER ADVIA DIGOXIN ASSAY FOR THE INTEGRATED MODULE SYSTEM (November 14, 2003)
  • K023058 — QMS DIGOXIN REAGENT SYSTEM ON THE ABBOTT AEROSET SYSTEM (October 24, 2002)
  • K012301 — IMMULITE 2000 DIGOXIN, MODELS L2KDI2 (200 TESTS) AND L2KDI6 (600 TESTS) (September 19, 2001)
  • K011302 — RANDOX DIGOXIN (July 2, 2001)

FDA data resources