510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K103373Substantially Equivalent

Synchron Systems Cholinesterase (Chex) Model A53722

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

K103373 is the FDA 510(k) clearance record for SYNCHRON SYSTEMS CHOLINESTERASE (CHEX) MODEL A53722, a class I device, cleared for Beckman Coulter, Inc. on under FDA product code DIH (Colorimetry, Cholinesterase). FDA records list 1,204 510(k) clearances for Siemens Healthcare Diagnostics Inc., from to . As of , FDA records show no recalls naming K103373.

Clearance record

Decision date
Received
(82 days to decision)
Product code
DIH Colorimetry, Cholinesterase
Regulation
21 CFR 862.3240
Device class
Class I
Review panel
Clinical Toxicology
Applicant
Beckman Coulter, Inc. 250 S. Kraemer Blvd., Brea CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DIH

Trailing 12 months

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

FDA records show no clearances under product code DIH in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DIH, 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