510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K955097Substantially Equivalent

Amerlite Mab Ft4 Assay

Kodak Clinical Diagnostics, Ltd., Buckinghamshire, GB / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K955097 is the FDA 510(k) clearance record for AMERLITE MAB FT4 ASSAY, a class II device, cleared for Kodak Clinical Diagnostics, Ltd. on under FDA product code CEC (Radioimmunoassay, Free Thyroxine). FDA records list one 510(k) clearance for Kodak Clinical Diagnostics, Ltd. As of , FDA records show no recalls naming K955097.

Clearance record

Decision date
Received
(43 days to decision)
Product code
CEC Radioimmunoassay, Free Thyroxine
Regulation
21 CFR 862.1695
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Kodak Clinical Diagnostics, Ltd. Nightingales Ln., Buckinghamshire, GB
510(k) summary
Statement
Third party review
No

Clearances, product code CEC

Trailing 12 months

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

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