510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K893469Substantially Equivalent

Amerlite Tbg Assay, Lan.0005/1005 240/144 Test Kit

Amersham Corp., Arlington Heights IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K893469 is the FDA 510(k) clearance record for AMERLITE TBG ASSAY, LAN.0005/1005 240/144 TEST KIT, a class II device, cleared for Amersham Corp. on under FDA product code CEE (Radioimmunoassay, Thyroxine-Binding Globulin). FDA records list 94 510(k) clearances for Amersham Corp., from to . As of , FDA records show no recalls naming K893469.

Clearance record

Decision date
Received
(103 days to decision)
Product code
CEE Radioimmunoassay, Thyroxine-Binding Globulin
Regulation
21 CFR 862.1685
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Amersham Corp. 2636 S. Clearbrook Dr., Arlington Heights IL
Third party review
No

Clearances, product code CEE

Trailing 12 months

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

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