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DFZ — Igg (Gamma Chain Specific), Antigen, Antiserum, Control Class II

FDA Device Classification

Classification Details

Product Code
DFZ
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
K092283siemens healthcare diagnosticsDIMENSION VISTA IMMUNOGLOBULIN IGG SUBCLASSS 1FLEX REAGENT CARTRIDGE, DIMENSION October 21, 2009
K021081binding siteHUMAN IGG SUBCLASS LIQUID REAGENT KITS FOR USE ON THE HITACHI 911/7070 TURBIDIMEJune 17, 2002
K020823sanquin blood supply foundationPELICLASS HUMAN IGG SUBCLASS NEPHELOMETRIC IMMAGE KITMay 14, 2002
K955906boehringer mannheimBOEHRINGER MANNHEIM IGG ASSAYFebruary 9, 1996
K940422binding siteIGG SUBCLASS SINGLE DILUTION DIAGNOSTIC KIT FOR USE WITH THE BECKMAN ARRAY ANALYMay 27, 1994
K812821immulokH-103 IGG, H-104 IGA, H-105 IGMOctober 26, 1981
K803272icl scientificAUTOMATED IMMUNOPRECIPITIN METHOD/ICGJanuary 26, 1981
K790709kent laboratoriesANTISERUM TO RABBIT IMMUNOGLOBULINAugust 16, 1979
K790720kent laboratoriesANTISERA TO RABBIT IMMUNOGLOBULINAugust 16, 1979