510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K922945Substantially Equivalent

Technicon Dax System Thyroxine (T4) Method

Kulzer GmbH, Tarrytown NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K922945 is the FDA 510(k) clearance record for TECHNICON DAX SYSTEM THYROXINE (T4) METHOD, a class II device, cleared for Heraeus Kulzer, Inc. on under FDA product code CDX (Radioimmunoassay, Total Thyroxine). FDA records list 205 510(k) clearances for KULZER GMBH, from to . As of , FDA records show no recalls naming K922945.

Clearance record

Decision date
Received
(118 days to decision)
Product code
CDX Radioimmunoassay, Total Thyroxine
Regulation
21 CFR 862.1700
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Heraeus Kulzer, Inc. 511 Benedict Ave., Tarrytown NY
510(k) summary
Statement
Third party review
No

Clearances, product code CDX

Trailing 12 months

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

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