HUMAN IGG SUBCLASS RID KIT

Method, Immunodiffusion, Immunoglobulins (g, A, M)

JANSSEN BIOCHIMICA

The following data is part of a premarket notification filed by Janssen Biochimica with the FDA for Human Igg Subclass Rid Kit.

Pre-market Notification Details

Device IDK915650
510k NumberK915650
Device Name:HUMAN IGG SUBCLASS RID KIT
ClassificationMethod, Immunodiffusion, Immunoglobulins (g, A, M)
Applicant JANSSEN BIOCHIMICA 40 KINGSBRIDGE RD. Piscataway,  NJ  08855
ContactRuth Wasserman
CorrespondentRuth Wasserman
JANSSEN BIOCHIMICA 40 KINGSBRIDGE RD. Piscataway,  NJ  08855
Product CodeCGM  
CFR Regulation Number866.5510 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-12-18
Decision Date1992-03-26

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