510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K901475Substantially Equivalent

Clinical Assays(tm) Gammacoat(tm) M [125I] T4

Baxter Healthcare Corporation, Miami FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K901475 is the FDA 510(k) clearance record for CLINICAL ASSAYS(TM) GAMMACOAT(TM) M [125I] T4, a class II device, cleared for Baxter Healthcare Corp on under FDA product code CDX (Radioimmunoassay, Total Thyroxine). FDA records list 570 510(k) clearances for Baxter Healthcare Corp, from to . As of , FDA records show no recalls naming K901475.

Clearance record

Decision date
Received
(85 days to decision)
Product code
CDX Radioimmunoassay, Total Thyroxine
Regulation
21 CFR 862.1700
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Baxter Healthcare Corp P.O.Box 520672, Miami FL
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