Gamma Stick Cortisol Ria Kit/Stick Kit

FDA 510(k) K800538 · Alpha Gamma Laboratory

Substantially Equivalent

510(k) numberK800538

Submission

Device name
Gamma Stick Cortisol Ria Kit/Stick Kit
Applicant
Alpha Gamma Laboratory
Mchenry, IL, US
Received
March 10, 1980
Decision date
April 24, 1980
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
CGR – Radioimmunoassay, Cortisol
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1205
Specialty
Clinical Chemistry

Other 510(k)s with product code CGR

510(k)DeviceApplicantDecision
K242190Access Cortisol; DxC 500i Clinical AnalyzerCGR · Traditional Beckman Coulter, Inc.03/05/2025SE
K223038Access CortisolCGR · Traditional Beckman Coulter, Inc.02/08/2023SE
K202136IDS CortisolCGR · Traditional Immunodiagnostic Systems , Ltd.04/13/2021SE
K203270IMMULITE/IMMULITE® 1000 CortisolCGR · Traditional Siemens Healthcare Diagnostics Products, Ltd.01/15/2021SE
K202826IMMULITE® 2000 CortisolCGR · Traditional Siemens Healthcare Diagnostics Products, Ltd.01/15/2021SE
K062626Cortisol ElisaCGR · Traditional Ibl-Hamburg GmbH12/20/2006SE
K060480Vitros Immunodiagnostic Products Cortisol Reagent Pack and Calibrators and Metabolism…CGR · Traditional Ortho-Clinical Diagnostics07/03/2006SE
K052359Ibl Cortisol Lia Test KitCGR · Traditional Lehnus & Associates Consulting10/03/2005SE
K050202Cortisol and Cortisol Calibrators on the Access Immunoassay SystemsCGR · Special Beckman Coulter, Inc.02/09/2005SE
K042689Nichols Advantage CortisolCGR · Traditional Nichols Institute Diagnostics12/09/2004SE

More from Nichols Institute Diagnostics

510(k)DeviceDecision
K810011Gamma Stick 125-1 Tobramycin Ria KitKLB · Traditional 01/28/1981SE
K800537Gamma Stick Gentamicin Ria KitDJB · Traditional 04/24/1980SE
K780492Gamma Stik 125I T3 Uptake KitCDP · Traditional 04/28/1978SE

Questions and answers

When was Gamma Stick Cortisol Ria Kit/Stick Kit cleared by the FDA?

Gamma Stick Cortisol Ria Kit/Stick Kit (K800538) received a 510(k) decision of Substantially Equivalent on April 24, 1980, 45 days after the submission was received.

What is the product code of K800538?

The FDA product code is CGR – Radioimmunoassay, Cortisol, a Class II (moderate risk) device regulated under 21 CFR 862.1205.