510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K854944Substantially Equivalent

Tdx Immunoglobulin M Diagnostic Kit

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

K854944 is the FDA 510(k) clearance record for TDX IMMUNOGLOBULIN M DIAGNOSTIC KIT, a class II device, cleared for Abbott Laboratories on under FDA product code DAH (Gamma Globulin, Antigen, Antiserum, Control). FDA records list 1,478 510(k) clearances for Abbott Medical, from to . As of , FDA records show no recalls naming K854944.

Clearance record

Decision date
Received
(260 days to decision)
Product code
DAH Gamma Globulin, Antigen, Antiserum, Control
Regulation
21 CFR 866.5510
Device class
Class II
Review panel
Immunology
Applicant
Abbott Laboratories 1921 Hurd Dr., Irving TX
Third party review
No

Clearances, product code DAH

Trailing 12 months

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

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