Amerlite Mab FT4 Assay

FDA 510(k) K955097 · Kodak Clinical Diagnostics, Ltd.

Substantially Equivalent

510(k) numberK955097

Submission

Device name
Amerlite Mab FT4 Assay
Applicant
Kodak Clinical Diagnostics, Ltd.
Buckinghamshire, GB
Received
November 7, 1995
Decision date
December 20, 1995
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
CEC – Radioimmunoassay, Free Thyroxine
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1695
Specialty
Clinical Chemistry

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Questions and answers

When was Amerlite Mab FT4 Assay cleared by the FDA?

Amerlite Mab FT4 Assay (K955097) received a 510(k) decision of Substantially Equivalent on December 20, 1995, 43 days after the submission was received.

What is the product code of K955097?

The FDA product code is CEC – Radioimmunoassay, Free Thyroxine, a Class II (moderate risk) device regulated under 21 CFR 862.1695.