510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K193397Substantially Equivalent

ADVIA Centaur® Digoxin assay

Siemens Healthcare Diagnostics Inc., Tarrytown NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K193397 is the FDA 510(k) clearance record for ADVIA Centaur® Digoxin assay, a class II device, cleared for Siemens Healthcare Diagnostics, Inc. on under FDA product code KXT (Enzyme Immunoassay, Digoxin). FDA records list 1,204 510(k) clearances for Siemens Healthcare Diagnostics, Inc., from to . As of , FDA records show no recalls naming K193397.

Clearance record

Decision date
Received
(588 days to decision)
Product code
KXT Enzyme Immunoassay, Digoxin
Regulation
21 CFR 862.3320
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Siemens Healthcare Diagnostics, Inc. 511 Benedict Ave., Tarrytown NY
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KXT

Trailing 12 months

FDA records hold no clearances under product code KXT in the trailing twelve months.

FDA records show no clearances under product code KXT in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KXT, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260