FDA 510(k) Applications for Medical Device Product Code "CKG"
(Radioimmunoassay, Acth)

FDA 510(k) Number Applicant Device Name Decision Date
K960066 DIAGNOSTIC PRODUCTS CORP. IMMULITE ACTH 02/16/1996
K002638 FUTURE DIAGNOSTICS B.V. FUTURE DIAGNOSTICS B.V. STAT-ACTH KIT 01/17/2001
K960491 HAWKSLEY & SONS LTD. MICRO HAEMATOCRIT CENTRIFUGE 10/18/1996
K223867 Immunodiagnostic Systems Limited IDS ACTH II 08/18/2023
K962601 NICHOLS INSTITUTE DIAGNOSTICS NICHOLS ADVANTAGE CHEMILUMINESCENCE ADRENOCORTICOTROPIC HORMONE 12/24/1996
K060585 ROCHE DIAGNOSTICS CORP. ROCHE ELECSYS- ACTH,ACTH CALSET,ACTH CALCHECK,PRECICONTROL ACTH 05/03/2006
K982608 SANGUI BIOTECH, INC. SANGUI BIOTECH, INC. ACTH (ADRENOCORTICOTROPIC HORMONE) ELISA KIT 08/19/1998
K050748 SCANTIBODIES LABORATORY, INC. ACTH IMMUNORADIOMETRIC (IRMA) ASSAY KIT, MODEL 3KG011 05/20/2005
K021032 SCANTIBODIES LABORATORY, INC. ACTH IMMUNORADIOMETRIC (IRMA) DIAGNOSTIC ASSAY KIT, MODEL #3KG100 06/03/2002
K111335 Tosoh BioScience, Inc. ST AIA-PACK ACTH, AND ST AIA-PACK ACTH CALIBRATOR SET MODEL 025221 AND 025321 12/01/2011


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