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

FDA 510(k) Number Applicant Device Name Decision Date
K833934 CLINETICS CORP. ADRENOCORTICOTROPIC HORMONE TEST 04/04/1984
K860311 COMPAGNIE ORIS INDUSTRIE, S.A. ACTHK-PR RIA KIT 04/07/1986
K831826 DAMON CORP. ADRENOCORTICOTROPIN RADIO-IMMUNOASSAY 07/18/1983
K840018 DIAGNOSTIC PRODUCTS CORP. DPC ACTH KIT 03/23/1984
K960066 DIAGNOSTIC PRODUCTS CORP. IMMULITE ACTH 02/16/1996
K842249 DIAGNOSTIC SYSTEMS LABORATORIES, INC. ACTH NORMAL RANGE 08/15/1984
K830893 DIAGNOSTIC SYSTEMS LABORATORIES, INC. ACTH RIA SYSTEM-DSI 2300 04/27/1983
K900147 DIAGNOSTIC SYSTEMS LABORATORIES, INC. MODIFIED DSL-2300 ACTH RIA 03/01/1990
K850053 EURO-DIAGNOSTICS BV BACI 6 -ADRENOCORTICOTROOP HORMONE 04/08/1985
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
K850882 IMMUNO NUCLEAR CORP. ACTH II BY RADIOIMMUNOASSAY 03/21/1985
K811565 IMMUNO NUCLEAR CORP. ACTH RADIOIMMUNOASSAY KIT 06/25/1981
K940271 INCSTAR CORP. INCSTAR ACTH IRMA 08/02/1994
K915727 MITSUBISHI YUKA AMERICA, INC. ACTH IRMA KIT II " MITSUBISHI YUKA" 03/02/1992
K926396 NICHOLS INSTITUTE ADRENOCORTICOTROPIC/ACTH ANALYSIS PRODUCT 07/27/1993
K833471 NICHOLS INSTITUTE DIAGNOSTICS ADRENOCOR TICOTROPIC HORMONE RADIOIMM 01/11/1984
K882741 NICHOLS INSTITUTE DIAGNOSTICS ALLEGRO ACTH IMMUNOASSAY KIT 65 AND 130 TUBES 08/30/1988
K962601 NICHOLS INSTITUTE DIAGNOSTICS NICHOLS ADVANTAGE CHEMILUMINESCENCE ADRENOCORTICOTROPIC HORMONE 12/24/1996
K831855 RADIOASSAY SYSTEMS LABORATORIES, INC. HATCH KIT 07/28/1983
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
K910178 SCIENCE REGULATORY SERVICES INTL. ACTH IRMA KIT "MITSUBISHI YUKA" 05/22/1991
K822115 SERAGEN DIAGNOSTICS, INC. SERAGAN ACTH125 I-RIA KIT 10/18/1982
K833849 SYNCOR INTL. CORP. ACTH RIA 01/30/1984
K844181 SYNCOR INTL. CORP. ACTH RIA 11/27/1984
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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