Biocheck Total T4 Enzyme Immunoassay Test Kit, Model BC-1007

Q: What is the product code of K991432?

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) K991432 · Biocheck, Inc.

Substantially Equivalent

510(k) numberK991432

Submission

Device name: Biocheck Total T4 Enzyme Immunoassay Test Kit, Model BC-1007
Applicant: Biocheck, Inc.
Northridge, CA, US
Received: April 26, 1999
Decision date: June 2, 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

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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
K982298	Opticoat T4 Eia KitKLI · Traditional	Biotecx Laboratories, Inc.	02/03/1999SE
K983440	Abbott Architect Total T4KLI · Traditional	Abbott Laboratories	11/25/1998SE

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Questions and answers

When was Biocheck Total T4 Enzyme Immunoassay Test Kit, Model BC-1007 cleared by the FDA?

Biocheck Total T4 Enzyme Immunoassay Test Kit, Model BC-1007 (K991432) received a 510(k) decision of Substantially Equivalent on June 2, 1999, 37 days after the submission was received.

What is the product code of K991432?

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