Question 1

Who is the manufacturer of T3(125) RADIOIMMUNOASSAY KIT?

Accepted Answer

Technia Diagnostics , Ltd. filed the 510(k) submission for T3(125) RADIOIMMUNOASSAY KIT (K801843).

Question 2

What is the FDA product code for T3(125) RADIOIMMUNOASSAY KIT?

Accepted Answer

CDP. It is classified under 21 CFR 862.1710 as a Class 2 device in the Clinical Chemistry panel.

Question 3

When was T3(125) RADIOIMMUNOASSAY KIT cleared by the FDA?

Accepted Answer

Sep 16, 1980 (decision: SESE).

Question 4

What is the regulatory pathway for T3(125) RADIOIMMUNOASSAY KIT?

Accepted Answer

510(k) clearance (submission type: Traditional).

Question 5

Who can help prepare an FDA 510(k) submission like T3(125) RADIOIMMUNOASSAY KIT?

Accepted Answer

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Record ID	K801843
Device Name	T3(125) RADIOIMMUNOASSAY KIT
Applicant	Technia Diagnostics , Ltd.
Product Code	CDP · Clinical Chemistry
Decision Date	Sep 16, 1980
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 862.1710
Device Class	Class 2

T3(125) RADIOIMMUNOASSAY KIT

Device Facts

Regulatory Classification

Identification