ANTISERUM TO HUMAN HEMOPEXIN

Hemopexin, 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 Hemopexin.

Pre-market Notification Details

Device IDK790713
510k NumberK790713
Device Name:ANTISERUM TO HUMAN HEMOPEXIN
ClassificationHemopexin, Antigen, Antiserum, Control
Applicant KENT LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeCZX  
CFR Regulation Number866.5490 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1979-04-12
Decision Date1979-09-04

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