ANTISERUM TO HUMAN FC

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

KENT LABORATORIES, INC.

The following data is part of a premarket notification filed by Kent Laboratories, Inc. with the FDA for Antiserum To Human Fc.

Pre-market Notification Details

Device IDK790715
510k NumberK790715
Device Name:ANTISERUM TO HUMAN FC
ClassificationIgg (fc Fragment Specific), Antigen, Antiserum, Control
Applicant KENT LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeDAS  
CFR Regulation Number866.5530 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1979-04-12
Decision Date1979-08-16

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