Cedia T4 Mab Assay

Q: When was Cedia T4 Mab Assay cleared by the FDA?

Cedia T4 Mab Assay (K943019) received a 510(k) decision of Substantially Equivalent on October 20, 1994, 118 days after the submission was received.

Q: What is the product code of K943019?

The FDA product code is KLI – Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine, a Class II (moderate risk) device regulated under 21 CFR 862.1700.

FDA 510(k) K943019 · Microgenics Corp.

Substantially Equivalent

510(k) numberK943019

Submission

Device name: Cedia T4 Mab Assay
Applicant: Microgenics Corp.
Concord, CA, US
Received: June 24, 1994
Decision date: October 20, 1994
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: KLI – Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
Device class: Class II (moderate risk)
Regulation: 21 CFR 862.1700
Specialty: Clinical Chemistry

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K001603	Reprobead T4 Enzyme Immunoassay Reagent Kit (Catalog# 105)KLI · Traditional	Repromedix Corp.	10/05/2000SE
K000600	Syva Emit 2000 Thyroxine Assay, CalibratorsKLI · Traditional	Syva Co., Dade Behring, Inc.	03/27/2000SE
K991432	Biocheck Total T4 Enzyme Immunoassay Test Kit, Model BC-1007KLI · Traditional	Biocheck, Inc.	06/02/1999SE
K982298	Opticoat T4 Eia KitKLI · Traditional	Biotecx Laboratories, Inc.	02/03/1999SE

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Questions and answers

When was Cedia T4 Mab Assay cleared by the FDA?

Cedia T4 Mab Assay (K943019) received a 510(k) decision of Substantially Equivalent on October 20, 1994, 118 days after the submission was received.

What is the product code of K943019?

The FDA product code is KLI – Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine, a Class II (moderate risk) device regulated under 21 CFR 862.1700.