ANTISERUM TO HUMAN IGG

Igg, 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 Igg.

Pre-market Notification Details

Device IDK790704
510k NumberK790704
Device Name:ANTISERUM TO HUMAN IGG
ClassificationIgg, Antigen, Antiserum, Control
Applicant KENT LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeDEW  
CFR Regulation Number866.5510 [🔎]
DecisionSe - Postmarket Surveillance Required (SESP)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1979-04-12
Decision Date1979-04-12

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