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CKG — Radioimmunoassay, Acth Class II

FDA Device Classification

Classification Details

Product Code
CKG
Device Class
Class II
Regulation Number
862.1025
Submission Type
Review Panel
CH
Medical Specialty
Clinical Chemistry
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K223867immunodiagnostic systems limitedIDS ACTH IIAugust 18, 2023
K111335tosoh bioscienceST AIA-PACK ACTH, AND ST AIA-PACK ACTH CALIBRATOR SET MODEL 025221 AND 025321December 1, 2011
K060585roche diagnosticsROCHE ELECSYS- ACTH,ACTH CALSET,ACTH CALCHECK,PRECICONTROL ACTHMay 3, 2006
K050748scantibodies laboratoryACTH IMMUNORADIOMETRIC (IRMA) ASSAY KIT, MODEL 3KG011May 20, 2005
K021032scantibodies laboratoryACTH IMMUNORADIOMETRIC (IRMA) DIAGNOSTIC ASSAY KIT, MODEL #3KG100June 3, 2002
K002638future diagnosticsFUTURE DIAGNOSTICS B.V. STAT-ACTH KITJanuary 17, 2001
K982608sangui biotechSANGUI BIOTECH, INC. ACTH (ADRENOCORTICOTROPIC HORMONE) ELISA KITAugust 19, 1998
K962601nichols institute diagnosticsNICHOLS ADVANTAGE CHEMILUMINESCENCE ADRENOCORTICOTROPIC HORMONEDecember 24, 1996
K960491hawksley and sonsMICRO HAEMATOCRIT CENTRIFUGEOctober 18, 1996
K960066diagnostic productsIMMULITE ACTHFebruary 16, 1996
K940271incstarINCSTAR ACTH IRMAAugust 2, 1994
K926396nichols instituteADRENOCORTICOTROPIC/ACTH ANALYSIS PRODUCTJuly 27, 1993
K915727mitsubishi yuka americaACTH IRMA KIT II MITSUBISHI YUKAMarch 2, 1992
K910178science regulatory services intlACTH IRMA KIT MITSUBISHI YUKAMay 22, 1991
K900147diagnostic systems laboratoriesMODIFIED DSL-2300 ACTH RIAMarch 1, 1990
K882741nichols institute diagnosticsALLEGRO ACTH IMMUNOASSAY KIT 65 AND 130 TUBESAugust 30, 1988
K860311compagnie oris industrieACTHK-PR RIA KITApril 7, 1986
K850053euro-diagnosticsBACI 6 -ADRENOCORTICOTROOP HORMONEApril 8, 1985
K850882immuno nuclearACTH II BY RADIOIMMUNOASSAYMarch 21, 1985
K844181syncor intlACTH RIANovember 27, 1984