Zetaphase T3 Uptake Diagnostic Kit

Q: What is the product code of K821553?

The FDA product code is KHQ – Radioassay, Triiodothyronine Uptake, a Class II (moderate risk) device regulated under 21 CFR 862.1715.

FDA 510(k) K821553 · Amf Biological and Diagnostics Co.

Substantially Equivalent

510(k) numberK821553

Submission

Device name: Zetaphase T3 Uptake Diagnostic 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: KHQ – Radioassay, Triiodothyronine Uptake
Device class: Class II (moderate risk)
Regulation: 21 CFR 862.1715
Specialty: Clinical Chemistry

Other 510(k)s with product code KHQ

510(k)	Device	Applicant	Decision
K981375	Ace T Uptake Reagent Tu CalibratorsKHQ · Traditional	Schiapparelli Biosystems, Inc.	06/10/1998SE
K980088	T-Uptake Microplate EiaKHQ · Traditional	Monobind	02/04/1998SE
K970539	Chiron Diagnostics ACS:180TU PKHQ · Traditional	Chiron Diagnostics Corp.	03/24/1997SE
K964308	Vitros Immunodiagnostics Products T3 Uptake Reagent Pack (GEM.1025) and T3 Uptake…KHQ · Traditional	Johnson & Johnson Clinical Diagnostics, Inc.	11/27/1996SE
K961488	Elecsys T-Uptake AssayKHQ · Traditional	Boehringer Mannheim Corp.	06/12/1996SE
K954807	Cedia T Uptake AssayKHQ · Traditional	Boehringer Mannheim Corp.	12/21/1995SE
K951586	T-Uptake Eia TestKHQ · Traditional	Diagnostic Reagents, Inc.	05/15/1995SE
K933414	Stratus(R) Thyroid Uptake Fluor Enzyme ImmunoassayKHQ · Traditional	Baxter Diagnostics, Inc.	11/22/1994SE
K934312	Axsym(Tm) T-UptakeKHQ · Traditional	Abbott Laboratories	06/21/1994SE
K935816	Vidas T UptakeKHQ · Traditional	Biomerieux Vitek, Inc.	03/22/1994SE

More from Biomerieux Vitek, Inc.

510(k)	Device	Decision
K852418	QCM-SP1(NORMAL Concenttration) & SP2(ABNORMAL)JJY · Traditional	07/15/1985SE
K821931	Zeta-CortCGR · Traditional	07/22/1982SE
K821554	Zetaphase T4 Radioimmunoassay Diag. KitCDX · Traditional	06/25/1982SE
K812329	Zeta-Sera DKIS · Traditional	09/01/1981SE

Questions and answers

When was Zetaphase T3 Uptake Diagnostic Kit cleared by the FDA?

Zetaphase T3 Uptake Diagnostic Kit (K821553) 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 K821553?

The FDA product code is KHQ – Radioassay, Triiodothyronine Uptake, a Class II (moderate risk) device regulated under 21 CFR 862.1715.