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510(k) K915602

SRI DIGOXIN ENZYME IMMUNOASSAY by Serono-Baker Diagnostics, Inc. — Product Code KXT

K915602 is an FDA 510(k) premarket notification submitted by Serono-Baker Diagnostics, Inc. for the device "SRI DIGOXIN ENZYME IMMUNOASSAY". The FDA issued a decision of Substantially Equivalent on Jan 17, 1992. The device falls under product code KXT (Enzyme Immunoassay, Digoxin), a Class II device regulated under 21 CFR 862.3320. Serono-Baker Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Jan 17, 1992
Date Received
Dec 13, 1991
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 Serono-Baker Diagnostics, Inc.

  • K924257 — TESTOSTERONE SEROZYME(TM) ENZYME IMMUNOASSAY (Nov 30, 1992)
  • K914886 — SRI(TM) CORTISOL ENZYME IMMUNOASSAY(MAG SOL PHASE) (Mar 2, 1992)
  • K915164 — SRI TESTOSTERONE ENZYME IMMUNOASSAY (Mar 2, 1992)
  • K912937 — SR1 FREE T4 ENZYME IMMUNOASSAY (Nov 19, 1991)
  • K914462 — SRI PROGESTERONE ENZYME IMMUNOASSAY(MAG SOLD PHAS) (Oct 23, 1991)
  • K911912 — SR1 T3 UPTAKE ENZYME IMMUNOASSAY(MAG SOLID-PHASE) (Sep 18, 1991)
  • K911217 — SR1 T4 ENZYME IMMUNOASSAY (MAGNETIC SOLID-PHASE) (Aug 16, 1991)
  • K912318 — ESTRADIOL SEROZYME ENZYME IMMUNO (MAG SOLID-PHASE) (Jul 25, 1991)
  • K911396 — SR1 ESTRADIOL ENZYME IMMUNOASSAY (May 28, 1991)
  • K910837 — SRI TSH IMMUNENZYMETRIC ASSAY (May 24, 1991)

Other clearances for product code KXT

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

FDA data resources