510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K982935Substantially Equivalent

Synchron Systems Digoxin (Dign) Reagent, Synchron Systems Drug Calibrator

Siemens Healthcare Diagnostics Inc., Brea CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K982935 is the FDA 510(k) clearance record for SYNCHRON SYSTEMS DIGOXIN (DIGN) REAGENT, SYNCHRON SYSTEMS DRUG CALIBRATOR, a class II device, cleared for Beckman Coulter, 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 K982935.

Clearance record

Decision date
Received
(54 days to decision)
Product code
KXT Enzyme Immunoassay, Digoxin
Regulation
21 CFR 862.3320
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Beckman Coulter, Inc. 200 S. Kraemer Blvd.,M/S W-104, Brea CA
510(k) summary
Summary
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 November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KXT, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260