Opticoat T4 Eia Kit

Q: What is the product code of K982298?

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) K982298 · Biotecx Laboratories, Inc.

Substantially Equivalent

510(k) numberK982298

Submission

Device name: Opticoat T4 Eia Kit
Applicant: Biotecx Laboratories, Inc.
Houston, TX, US
Received: July 1, 1998
Decision date: February 3, 1999
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) statement 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
K103484	GSP Neonatal Thyroxine (T4)KLI · Traditional	Wallac Oy, A Subsidiary of Perkinelmer, Inc.	04/22/2011SE
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
K983440	Abbott Architect Total T4KLI · Traditional	Abbott Laboratories	11/25/1998SE

More from Abbott Laboratories

510(k)	Device	Decision
K981824	Opticoat T3 Eia KitCDP · Traditional	12/22/1998SE
K895407	Cortisol Clasp-Bead Eia KitCGR · Traditional	10/19/1989SE
K893620	T3 Clasp-Bead Eia KitCDP · Traditional	08/11/1989SE
K892853	T4 Clasp-Bead Eia KitKLI · Traditional	05/22/1989SE
K883765	TBG 125I Ria Kit, Radioimmuno. of Serum ThyroxineKHQ · Traditional	10/31/1988SE
K871211	Progesterone Clasp Radioimmunoassay KitJLS · Traditional	04/13/1987SE
K863188	HPL Ria KitJMX · Traditional	09/25/1986SE
K854876	Aldosterone Direct Ria KitKQN · Traditional	03/17/1986SE
K851540	Estradiol Direct Ria KitCHP · Traditional	06/06/1985SE
K844767	Radioimmunoassay of Human Serum Plasma or Urine toCGI · Traditional	02/01/1985SE

Questions and answers

When was Opticoat T4 Eia Kit cleared by the FDA?

Opticoat T4 Eia Kit (K982298) received a 510(k) decision of Substantially Equivalent on February 3, 1999, 217 days after the submission was received.

What is the product code of K982298?

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