GSP Neonatal Thyroxine (T4)

Q: What is the product code of K103484?

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) K103484 · Wallac Oy, A Subsidiary of Perkinelmer, Inc.

Substantially Equivalent

510(k) numberK103484

Submission

Device name: GSP Neonatal Thyroxine (T4)
Applicant: Wallac Oy, A Subsidiary of Perkinelmer, Inc.
Waltham, MA, US
Received: November 26, 2010
Decision date: April 22, 2011
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

Other 510(k)s with product code KLI

510(k)	Device	Applicant	Decision
K160495	VITROS® Automation SolutionsKLI · Traditional	Ortho-Clinical Diagnostics, Inc.	10/18/2016SE
K131515	Ace -Gt Reagent; Ace Lipase Ragent; Ace T4 ReagentKLI · Traditional	Alfa Wassermann	08/14/2013SE
K082638	Advia Centaur System with Streamlab Analytical WorkcellKLI · Traditional	Siemens Healthcare Diagnostics, Inc.	02/26/2009SE
K030860	Accubind Neonatal T4 Microplate Eia, Model 2625-300KLI · Traditional	Monobind	08/22/2003SE
K023369	Access Total T4 AssayKLI · Traditional	Beckman Coulter, Inc.	12/09/2002SE
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
K983440	Abbott Architect Total T4KLI · Traditional	Abbott Laboratories	11/25/1998SE

More from Abbott Laboratories

510(k)	Device	Decision
K173829	NeoLSD MSMS kitPQW · Traditional	07/18/2018SE
K133652	GSP Neonatal Total Galactose KitJIA · Traditional	04/28/2014SE
K110274	Autodelfia Neonatal Irt KitJNO · Traditional	06/10/2011SE

Questions and answers

When was GSP Neonatal Thyroxine (T4) cleared by the FDA?

GSP Neonatal Thyroxine (T4) (K103484) received a 510(k) decision of Substantially Equivalent on April 22, 2011, 147 days after the submission was received.

What is the product code of K103484?

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