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510(k) K896863

DIGOXIN-EIA-XT by In Vitro Diagnostics, Inc. — Product Code KXT

K896863 is an FDA 510(k) premarket notification submitted by In Vitro Diagnostics, Inc. for the device "DIGOXIN-EIA-XT". The FDA issued a decision of Substantially Equivalent on February 13, 1990. The device falls under product code KXT (Enzyme Immunoassay, Digoxin), a Class II device regulated under 21 CFR 862.3320. In Vitro Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 13, 1990
Date Received
December 6, 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 In Vitro Diagnostics, Inc.

  • K896867 — THYROID STIMULATING HORMONE-EIA-XT (February 23, 1990)
  • K896866 — LUTEINIZING HORMONE-EIA-XT (February 13, 1990)
  • K896865 — VITRO T4-EIA-XT (January 30, 1990)
  • K896925 — T UPTAKE ENZYME IMMUNOASSAY CRIMPED TUBE KIT (January 18, 1990)
  • K896864 — FOLLICLE STIMULATING HORMONE-EIA-XT (January 11, 1990)
  • K873832 — REAGENTS FOR USE ON CONTRAVES DC300, DC500, AL801 (November 23, 1987)
  • K871184 — FLAME PHOTOMETER STANDARD #60083 160 NA/8K (May 28, 1987)
  • K871183 — FLAME PHOTOMETER STANDARD #60082 140 NA/5K (May 28, 1987)
  • K871186 — CESIUM DILUENT 1.5 MMOL CS/L #60087 (May 28, 1987)
  • K871188 — LITHIUM INTERNAL STANDARD 1500 MEQ/L #60086 (May 28, 1987)

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