FT4 Radioimmunoassay

FDA 510(k) K934012 · Immunotech S.A.

Substantially Equivalent

510(k) numberK934012

Submission

Device name
FT4 Radioimmunoassay
Applicant
Immunotech S.A.
France, FR
Received
August 18, 1993
Decision date
November 16, 1993
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary 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 FT4 Radioimmunoassay cleared by the FDA?

FT4 Radioimmunoassay (K934012) received a 510(k) decision of Substantially Equivalent on November 16, 1993, 90 days after the submission was received.

What is the product code of K934012?

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