510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K854416Substantially Equivalent

Tdx Transferrin Diagnostic Kit

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

K854416 is the FDA 510(k) clearance record for TDX TRANSFERRIN DIAGNOSTIC KIT, a class II device, cleared for Abbott Laboratories on under FDA product code DDG (Transferrin, Antigen, Antiserum, Control). FDA records list 1,478 510(k) clearances for Abbott Medical, from to . As of , FDA records show no recalls naming K854416.

Clearance record

Decision date
Received
(109 days to decision)
Product code
DDG Transferrin, Antigen, Antiserum, Control
Regulation
21 CFR 866.5880
Device class
Class II
Review panel
Immunology
Applicant
Abbott Laboratories 1921 Hurd Dr., Irving TX
Third party review
No

Clearances, product code DDG

Trailing 12 months

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

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