Zetaphase T4 Radioimmunoassay Diag. Kit

Q: What is the product code of K821554?

The FDA product code is CDX – Radioimmunoassay, Total Thyroxine, a Class II (moderate risk) device regulated under 21 CFR 862.1700.

FDA 510(k) K821554 · Amf Biological and Diagnostics Co.

Substantially Equivalent

510(k) numberK821554

Submission

Device name: Zetaphase T4 Radioimmunoassay Diag. Kit
Applicant: Amf Biological and Diagnostics Co.
Mchenry, IL, US
Received: May 25, 1982
Decision date: June 25, 1982
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code: CDX – Radioimmunoassay, Total Thyroxine
Device class: Class II (moderate risk)
Regulation: 21 CFR 862.1700
Specialty: Clinical Chemistry

Other 510(k)s with product code CDX

510(k)	Device	Applicant	Decision
K961490	Elecsys T4 AssayCDX · Traditional	Boehringer Mannheim Corp.	06/13/1996SE
K954312	Active Thyroxine RiaCDX · Traditional	Diagnostic Systems Laboratories, Inc.	10/07/1995SE
K943416	Delfia Neonatal Thyroxine KitCDX · Traditional	Wallac OY	03/10/1995SE
K934384	Axsym(Tm) Total T4CDX · Traditional	Abbott Laboratories	06/21/1994SE
K932980	Total T4 Fpia Reagent Set/Calibrator #T-1039,T-116CDX · Traditional	Sigma Diagnostics, Inc.	10/18/1993SE
K933426	Stratus(R) Total THYROXINE(T4) Fluor Enzyme ImmunoCDX · Traditional	Baxter Diagnostics, Inc.	08/26/1993SE
K931295	Iq TT4 AssayCDX · Traditional	Becton Dickinson Advanced Diagnostics	07/20/1993SE
K926563	Autobead(Tm) T4 Enzyme Immunoassay Test KitCDX · Traditional	Bio-Chem Laboratory Systems, Inc.	03/18/1993SE
K925110	Abbott Imx T4CDX · Traditional	Abbott Laboratories	01/26/1993SE
K925109	Abbott Tdx/Tdxflx TT4CDX · Traditional	Abbott Laboratories	01/04/1993SE

More from Abbott Laboratories

510(k)	Device	Decision
K852418	QCM-SP1(NORMAL Concenttration) & SP2(ABNORMAL)JJY · Traditional	07/15/1985SE
K821931	Zeta-CortCGR · Traditional	07/22/1982SE
K821553	Zetaphase T3 Uptake Diagnostic KitKHQ · Traditional	06/25/1982SE
K812329	Zeta-Sera DKIS · Traditional	09/01/1981SE

Questions and answers

When was Zetaphase T4 Radioimmunoassay Diag. Kit cleared by the FDA?

Zetaphase T4 Radioimmunoassay Diag. Kit (K821554) received a 510(k) decision of Substantially Equivalent on June 25, 1982, 31 days after the submission was received.

What is the product code of K821554?

The FDA product code is CDX – Radioimmunoassay, Total Thyroxine, a Class II (moderate risk) device regulated under 21 CFR 862.1700.