HUMAN IGG SUBCLASSES RID COMBI KIT (MODIFICATION)

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 Rid Combi Kit (modification).

Pre-market Notification Details

Device IDK943205
510k NumberK943205
Device Name:HUMAN IGG SUBCLASSES RID COMBI KIT (MODIFICATION)
ClassificationIgg (fc Fragment Specific), Antigen, Antiserum, Control
Applicant RESEARCH DIAGNOSTICS, INC. PLEASANT HILL RD. Flanders,  NJ  07836
ContactBret G Wien
CorrespondentBret G 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 Received1994-07-05
Decision Date1994-09-07

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