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JKR — Radioimmunoassay, Calcitonin Class II

FDA Device Classification

Classification Details

Product Code
JKR
Device Class
Class II
Regulation Number
862.1140
Submission Type
Review Panel
CH
Medical Specialty
Clinical Chemistry
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K182012axis-shield diagnostics limitedADVIA Centaur Calcitonin (CALCT) assayDecember 21, 2018
K132828roche diagnosticsELECSYS CALCITONIN; IMMUNOASSAY, CALSET, CALCHECK 5; ELECSYS PRECICONTROL VARIA December 4, 2013
K060578scantibodies laboratoryCALCITONIN IMMUNORADIOMETRIC ASSAY (IRMA) (COATED TUBE VERSION)August 30, 2006
K023304diagnostic productsIMMULITE/IMMULITE 1000 CALCITONIN, MODEL LKCL AND IMMULITE 2000 CALCITONIN, MODEDecember 9, 2002
K990073kmi diagnosticsCALCITONINMay 11, 1999
K982491sangui biotechSANGUI BIOTECH, INC. CALCITONIN ELISA KITSeptember 3, 1998
K964635nichols institute diagnosticsNICHOLS ADVANTAGE CHEMILUMINESCENCE CALCITONIN KITMay 21, 1997
K961043scantibodies laboratorySCANTIBODIES CALCITONIN IMMUNORADIOMETRIC ASSAY (COATED BEAD TECHNOLOGY)May 6, 1996
K945961nichols institute diagnosticsCALCITONIN IMMUNOASSAY KITNovember 20, 1995
K951708cis-usELSA-HCTSeptember 5, 1995
K914429diagnostic systems laboratoriesDSL ULTRA-SENSITIVE CALCITONIN RIA (DSL 5200)January 15, 1992
K912536mitsubishi yuka americaCALCITONIN KIT MITSUBISHI YUKAJuly 18, 1991
K874087diagnostic systems laboratoriesMODIFIED CALCITONIN RIA KIT DSL #1200February 2, 1988
K872880endocrine associatesCALCITONIN RIA KITAugust 13, 1987
K861274diagnostic productsDOUBLE ANTIBODY CALCITONIN RIA KITJune 25, 1986
K854240diagnostic systems laboratoriesCALCITONIN RIA KITNovember 22, 1985
K842907nichols institute diagnosticsCALCITONIN RADIOIMMUNOASSAY KITSeptember 5, 1984
K821675diagnostic systems laboratoriesCALCITONIN RIA TEST KIT, DLS 1200June 22, 1982
K781909cambridge nuclear radiopharmaceuticalCALCITONIN 125January 10, 1979