FDA 510(k) Applications for Medical Device Product Code "CFQ"
(Radioimmunoassay, Immunoglobulins (G, A, M))

FDA 510(k) Number Applicant Device Name Decision Date
K890561 ATLANTIC ANTIBODIES SPQ(TM) ANTIBODY REAGENT SET II FOR IGM 02/23/1989
K990551 DADE BEHRING, INC. IGG FLEX REAGENT CARTRIDGE 03/25/1999
K990553 DADE BEHRING, INC. IGM FLEX REAGENT CARTRIDGE 03/22/1999
K990552 DADE BEHRING, INC. IMMUNOGLOBULIN A TEST SYSTEM 03/25/1999
K891188 HELENA LABORATORIES TITAN GEL IFE TRIVALENT ANTISERUM 03/22/1989
K951055 OLYMPUS AMERICA, INC. OLYMPUS IGA IMMUNOTURBIDIMETRIC REAGENT 04/17/1995
K951013 OLYMPUS AMERICA, INC. OLYMPUS IGG IMMUNOTURBIDIMETRIC REAGENT 04/17/1995
K950900 OLYMPUS AMERICA, INC. OLYMPUS IGM IMMUNOTURBIDIMETRIC REAGENT 03/27/1995
K981786 THE BINDING SITE, LTD. IGA MININEPH ANTISERUM 11/24/1999
K881827 THE BINDING SITE, LTD. IMMUNOGLOBULIN A TEST SYSTEM 06/10/1988
K881828 THE BINDING SITE, LTD. IMMUNOGLOBULIN M TEST SYSTEM 06/06/1988
K881928 THE BINDING SITE, LTD. MONOCLONAL RADIAL IMMUNODIFFUSION KIT 07/08/1988


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