FDA 510(k) Applications for Medical Device Product Code "DFZ"
(Igg (Gamma Chain Specific), Antigen, Antiserum, Control)

FDA 510(k) Number Applicant Device Name Decision Date
K955906 BOEHRINGER MANNHEIM CORP. BOEHRINGER MANNHEIM IGG ASSAY 02/09/1996
K803272 ICL SCIENTIFIC AUTOMATED IMMUNOPRECIPITIN METHOD/ICG 01/26/1981
K812821 IMMULOK, INC. H-103 IGG, H-104 IGA, H-105 IGM 10/26/1981
K790720 KENT LABORATORIES, INC. ANTISERA TO RABBIT IMMUNOGLOBULIN 08/16/1979
K790709 KENT LABORATORIES, INC. ANTISERUM TO RABBIT IMMUNOGLOBULIN 08/16/1979
K020823 SANQUIN BLOOD SUPPLY FOUNDATION PELICLASS HUMAN IGG SUBCLASS NEPHELOMETRIC IMMAGE KIT 05/14/2002
K092283 SIEMENS HEALTHCARE DIAGNOSTICS DIMENSION VISTA IMMUNOGLOBULIN IGG SUBCLASSS 1FLEX REAGENT CARTRIDGE, DIMENSION VISTA IMMUNOGLOBULIN IGG 10/21/2009
K021081 THE BINDING SITE, LTD. HUMAN IGG SUBCLASS LIQUID REAGENT KITS FOR USE ON THE HITACHI 911/7070 TURBIDIMETRIC ANALYSER 06/17/2002
K940422 THE BINDING SITE, LTD. IGG SUBCLASS SINGLE DILUTION DIAGNOSTIC KIT FOR USE WITH THE BECKMAN ARRAY ANALYZER 05/27/1994


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