N-Assay L Ast/Got

FDA 510(k) K980902 · Crestat Diagnostics, Inc.

Substantially Equivalent

510(k) numberK980902

Submission

Device name
N-Assay L Ast/Got
Applicant
Crestat Diagnostics, Inc.
Seattle, WA, US
Received
March 10, 1998
Decision date
March 26, 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)DeviceApplicantDecision
K093883Ast/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
K080485Aspartate Amino Transferase (Ast/Sgot) Test System, Asat (Got) FSCIT · Traditional Diasys Diagnostics Systems GmbH12/04/2008SE
K071525Activated Aspartate AminotransferaseCIT · Traditional Abbott Laboratories03/19/2008SE
K071580Ast/Got (Ifcc), Pyridoxal Phosphate, Ecal, Nortrol and AbtrolCIT · Traditional Thermofisher Scientific OY10/03/2007SE
K071211Cobas C 111 AnalyzerCIT · Traditional Roche Diagnostics07/30/2007SE
K060318Hepatic Enzymes on Abx Pentra 400 Clinical Chemistry AnalyzerCIT · Traditional Horiba Abx08/08/2006SE
K023551Wiener Lab Got (Ast) UV Aa LiquidaCIT · Traditional Wiener Laboratories Saic12/09/2002SE
K013698Ast (Sgot)CIT · Traditional Jas Diagnostics, Inc.12/21/2001SE
K013145Wiener Lab. Got (Ast) UV Aa. Weiner Lab. Got (Ast) UV Unitest, Models 10 * 20 ML Cat.…CIT · Traditional Wiener Laboratories Saic11/27/2001SE
K010488Atac Pak Ast Reagent KitCIT · Traditional Elan Holdings, Inc.04/09/2001SE

More from Elan Holdings, Inc.

510(k)DeviceDecision
K980883N-Assay Glu-UlCFR · Traditional 09/03/1998SE
K981276N-Assay L D-BilCIG · Traditional 05/01/1998SE
K981289N-Assay L T-BilCIG · Traditional 04/27/1998SE
K980900N-Assay Cpk-LCGS · Traditional 03/26/1998SE
K972257N-Assay Tia Antithrombin III Test KitDDQ · Traditional 10/20/1997SE
K971985N-Assay Tia Plasminogen Test KitGGP · Traditional 10/20/1997SE
K964296N-Assay Tia Apo B Test KitDER · Traditional 08/01/1997SE
K964294N-Assay Tia Apo A1/B Multi CalibratorDER · Traditional 08/01/1997SE
K964292N-Assay Tia Apo A1 Test KitDER · Traditional 08/01/1997SE
K965100N-Assay Tia ALPHA-1-ANTITRYPSIN Test KitDEM · Traditional 07/14/1997SE

Questions and answers

When was N-Assay L Ast/Got cleared by the FDA?

N-Assay L Ast/Got (K980902) received a 510(k) decision of Substantially Equivalent on March 26, 1998, 16 days after the submission was received.

What is the product code of K980902?

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