510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K960485Substantially Equivalent

Synchron Systems Iron (Fe)/total Iron Binding Capacity Reagents

Beckman Instruments, Inc., Brea CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K960485 is the FDA 510(k) clearance record for SYNCHRON SYSTEMS IRON (FE)/TOTAL IRON BINDING CAPACITY REAGENTS, a class I device, cleared for Beckman Instruments, Inc. on under FDA product code JMO (Ferrozine (Colorimetric) Iron Binding Capacity). FDA records list 281 510(k) clearances for Beckman Instruments, Inc., from to . As of , FDA records show no recalls naming K960485.

Clearance record

Decision date
Received
(98 days to decision)
Product code
JMO Ferrozine (Colorimetric) Iron Binding Capacity
Regulation
21 CFR 862.1415
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Beckman Instruments, Inc. 200 S. Kraemer Blvd., Brea CA
510(k) summary
Summary
Third party review
No

Clearances, product code JMO

Trailing 12 months

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

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