510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K923258Substantially Equivalent

Technicon Immuno 1 System Total Triiodothyronine

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

K923258 is the FDA 510(k) clearance record for TECHNICON IMMUNO 1 SYSTEM TOTAL TRIIODOTHYRONINE, a class II device, cleared for Heraeus Kulzer, Inc. on under FDA product code CDP (Radioimmunoassay, Total Triiodothyronine). FDA records list 205 510(k) clearances for KULZER GMBH, from to . As of , FDA records show no recalls naming K923258.

Clearance record

Decision date
Received
(83 days to decision)
Product code
CDP Radioimmunoassay, Total Triiodothyronine
Regulation
21 CFR 862.1710
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 CDP

Trailing 12 months

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

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