510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K851930Substantially Equivalent

Tdx Rea Iron/tibc

Abbott Medical, Irving TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K851930 is the FDA 510(k) clearance record for TDX REA IRON/TIBC, a class I device, cleared for Abbott Laboratories on under FDA product code JMO (Ferrozine (Colorimetric) Iron Binding Capacity). FDA records list 1,478 510(k) clearances for Abbott Medical, from to . As of , FDA records show no recalls naming K851930.

Clearance record

Decision date
Received
(22 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
Abbott Laboratories 1921 Hurd Dr., Irving TX
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 October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JMO, 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