Infinity Ast Reagent (Procedure No. 51)

Q: What is the product code of K980666?

The FDA product code is CIT – Nadh Oxidation/Nad Reduction, Ast/Sgot, a Class II (moderate risk) device regulated under 21 CFR 862.1100.

FDA 510(k) K980666 · Sigma Diagnostics, Inc.

Substantially Equivalent

510(k) numberK980666

Submission

Device name: Infinity Ast Reagent (Procedure No. 51)
Applicant: Sigma Diagnostics, Inc.
St. Louis, MO, US
Received: February 20, 1998
Decision date: March 20, 1998
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: CIT – Nadh Oxidation/Nad Reduction, Ast/Sgot
Device class: Class II (moderate risk)
Regulation: 21 CFR 862.1100
Specialty: Clinical Chemistry

Other 510(k)s with product code CIT

510(k)	Device	Applicant	Decision
K093883	Ast/Got 4+1 SL, Ast/Got 4+1 SL, Elical 2, Elitrol I, Elitrol II, Model ASSL-0250…CIT · Traditional	Seppim S.A.S.	09/20/2010SE
K080485	Aspartate Amino Transferase (Ast/Sgot) Test System, Asat (Got) FSCIT · Traditional	Diasys Diagnostics Systems GmbH	12/04/2008SE
K071525	Activated Aspartate AminotransferaseCIT · Traditional	Abbott Laboratories	03/19/2008SE
K071580	Ast/Got (Ifcc), Pyridoxal Phosphate, Ecal, Nortrol and AbtrolCIT · Traditional	Thermofisher Scientific OY	10/03/2007SE
K071211	Cobas C 111 AnalyzerCIT · Traditional	Roche Diagnostics	07/30/2007SE
K060318	Hepatic Enzymes on Abx Pentra 400 Clinical Chemistry AnalyzerCIT · Traditional	Horiba Abx	08/08/2006SE
K023551	Wiener Lab Got (Ast) UV Aa LiquidaCIT · Traditional	Wiener Laboratories Saic	12/09/2002SE
K013698	Ast (Sgot)CIT · Traditional	Jas Diagnostics, Inc.	12/21/2001SE
K013145	Wiener Lab. Got (Ast) UV Aa. Weiner Lab. Got (Ast) UV Unitest, Models 10 * 20 ML Cat.…CIT · Traditional	Wiener Laboratories Saic	11/27/2001SE
K010488	Atac Pak Ast Reagent KitCIT · Traditional	Elan Holdings, Inc.	04/09/2001SE

More from Elan Holdings, Inc.

510(k)	Device	Decision
K021162	Amax Density Coagulation Analyzer, Amax Denstiny Coagulation Analyzer-Eu, Amax Destiny…JPA · Traditional	08/30/2002SE
K020109	Sigma Diagnostics Accuclot la ControlGGC · Traditional	02/06/2002SE
K013549	Sigma Diagnostics Auto D-Dimer Calibrator, Model A7971DAP · Traditional	12/26/2001SE
K013545	Sigma Diagnostics Auto D-Dimer Control, Level 3, Model A8221DAP · Traditional	11/15/2001SE
K013544	Sigma Diagnostics Auto D-Dimer Control, Level 2, Model A8096DAP · Traditional	11/15/2001SE
K012410	Infinity Hba Kit, Models 537-A, 537-BLCP · Traditional	10/26/2001SE
K010652	Sigma Diagnostics Sigma-Cal, Model S2936JIX · Traditional	03/30/2001SE
K010158	Thrombomax-Hs with Calcium, Model T6540GGO · Traditional	03/22/2001SE
K003267	Sigma Diagnostics Auto D-Dimer, Model CRS126-ADAP · Traditional	03/15/2001SE
K003329	Sigma Dianostics Auto D-Dimer Control Level 2, Model A5217GGC · Traditional	03/01/2001SE

Questions and answers

When was Infinity Ast Reagent (Procedure No. 51) cleared by the FDA?

Infinity Ast Reagent (Procedure No. 51) (K980666) received a 510(k) decision of Substantially Equivalent on March 20, 1998, 28 days after the submission was received.

What is the product code of K980666?

The FDA product code is CIT – Nadh Oxidation/Nad Reduction, Ast/Sgot, a Class II (moderate risk) device regulated under 21 CFR 862.1100.