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
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


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