Flow-Pac SGPT Reagent

FDA 510(k) K830959 · Amresco, Inc.

Substantially Equivalent

510(k) numberK830959

Submission

Device name
Flow-Pac SGPT Reagent
Applicant
Amresco, Inc.
Mchenry, IL, US
Received
March 25, 1983
Decision date
May 4, 1983
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
CKA – Nadh Oxidation/Nad Reduction, Alt/Sgpt
Device class
Class I (low risk)
Regulation
21 CFR 862.1030
Specialty
Clinical Chemistry

Other 510(k)s with product code CKA

510(k)DeviceApplicantDecision
K120945Hitachi Clinical Analyzer S Test Reagent Cartridge Alt, Hitachi Clinical Analyzer S Test…CKA · Traditional Hitachi Chemical Diagnostics, Inc.06/07/2013SE
K113382Ace Alt ReagentCKA · Traditional Alfa Wassermann07/19/2012SE
K061020Dimension Vista Albumin, Alkaline Phosphatase, Aspartate Amino Transferase…CKA · Special Dade Behring, Inc.05/10/2006SE
K020487Careside AltCKA · Traditional Careside, Inc.06/04/2002SE
K980028Alt (GPT) Liquid Stable 2 Vial - Incorporating Dynamic Stabilization Technology - (DST)CKA · Traditional Trace America, Inc.02/02/1998SE
K973869Trace Reagent Line for the Cobas MiraCKA · Traditional Trace America, Inc.01/07/1998SE
K974003Alanine Aminotransferase-Sl Assay Catalogue Number 318-10, 318-30CKA · Traditional Diagnostic Chemicals , Ltd.12/05/1997SE
K971323Alt or SGPTCKA · Traditional Carolina Liquid Chemistries Corp.04/21/1997SE
K965134Alt/SgptCKA · Traditional Derma Media Lab., Inc.02/18/1997SE
K961123Alt Incorporating DSTCKA · Traditional Trace Scientific , Ltd.04/25/1996SE

More from Trace Scientific , Ltd.

510(k)DeviceDecision
K905618GGT ReagentJPZ · Traditional 02/26/1991SE
K904468Direct Bilirubin Reagent, 7776/7777/7576/7476/7176CIG · Traditional 01/17/1991SE
K905684Alkaline PhosphataseCJE · Traditional 12/28/1990SE
K905544Magnesium ReagentJGJ · Traditional 12/27/1990SE
K905284Hdl-Cholesterol Precipitant 7773/7573/7473/7173LBR · Traditional 12/11/1990SE
K904004Amrescocreat Kinase Reagent 7716/17,7516,7416,7116CGS · Traditional 12/11/1990SE
K905096GGT Reagents, 7738, 7739, 7538, 7438 & 7138JQB · Traditional 11/28/1990SE
K904381Diazo Colorimentry Direct BilirubinCIG · Traditional 10/12/1990SE
K903775Creatine PhosphokinaseCGS · Traditional 10/04/1990SE
K903829Ast ReagentCIT · Traditional 09/25/1990SE

Questions and answers

When was Flow-Pac SGPT Reagent cleared by the FDA?

Flow-Pac SGPT Reagent (K830959) received a 510(k) decision of Substantially Equivalent on May 4, 1983, 40 days after the submission was received.

What is the product code of K830959?

The FDA product code is CKA – Nadh Oxidation/Nad Reduction, Alt/Sgpt, a Class I (low risk) device regulated under 21 CFR 862.1030.