HUMAN IGG SUBCLASSES ELISA COMBI KIT

Igg (fc Fragment Specific), Antigen, Antiserum, Control

RESEARCH DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Research Diagnostics, Inc. with the FDA for Human Igg Subclasses Elisa Combi Kit.

Pre-market Notification Details

Device IDK943098
510k NumberK943098
Device Name:HUMAN IGG SUBCLASSES ELISA COMBI KIT
ClassificationIgg (fc Fragment Specific), Antigen, Antiserum, Control
Applicant RESEARCH DIAGNOSTICS, INC. PLEASANT HILL RD. Flanders,  NJ  07836
ContactBret Wien
CorrespondentBret Wien
RESEARCH DIAGNOSTICS, INC. PLEASANT HILL RD. Flanders,  NJ  07836
Product CodeDAS  
CFR Regulation Number866.5530 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-06-28
Decision Date1994-09-07

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