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CFQ — Radioimmunoassay, Immunoglobulins (G, A, M) Class II

FDA Device Classification

Classification Details

Product Code
CFQ
Device Class
Class II
Regulation Number
866.5510
Submission Type
Review Panel
IM
Medical Specialty
Immunology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K981786binding siteIGA MININEPH ANTISERUMNovember 24, 1999
K990552dade behringIMMUNOGLOBULIN A TEST SYSTEMMarch 25, 1999
K990551dade behringIGG FLEX REAGENT CARTRIDGEMarch 25, 1999
K990553dade behringIGM FLEX REAGENT CARTRIDGEMarch 22, 1999
K951055olympus americaOLYMPUS IGA IMMUNOTURBIDIMETRIC REAGENTApril 17, 1995
K951013olympus americaOLYMPUS IGG IMMUNOTURBIDIMETRIC REAGENTApril 17, 1995
K950900olympus americaOLYMPUS IGM IMMUNOTURBIDIMETRIC REAGENTMarch 27, 1995
K891188helena laboratoriesTITAN GEL IFE TRIVALENT ANTISERUMMarch 22, 1989
K890561atlantic antibodiesSPQ(TM) ANTIBODY REAGENT SET II FOR IGMFebruary 23, 1989
K881928binding siteMONOCLONAL RADIAL IMMUNODIFFUSION KITJuly 8, 1988
K881827binding siteIMMUNOGLOBULIN A TEST SYSTEMJune 10, 1988
K881828binding siteIMMUNOGLOBULIN M TEST SYSTEMJune 6, 1988