510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K003196Substantially Equivalent

Synchron Systems Ammonia Reagent

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

K003196 is the FDA 510(k) clearance record for SYNCHRON SYSTEMS AMMONIA REAGENT, a class I device, cleared for Beckman Coulter, Inc. on under FDA product code JIF (Enzymatic Method, Ammonia). FDA records list 1,204 510(k) clearances for Siemens Healthcare Diagnostics Inc., from to . As of , FDA records show no recalls naming K003196.

Clearance record

Decision date
Received
(71 days to decision)
Product code
JIF Enzymatic Method, Ammonia
Regulation
21 CFR 862.1065
Device class
Class I
Review panel
Clinical Chemistry
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 JIF

Trailing 12 months

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

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