ANTISERUM TO HUMAN IMMUNOGLOBULINS

Igg, Antigen, Antiserum, Control

ICL SCIENTIFIC

The following data is part of a premarket notification filed by Icl Scientific with the FDA for Antiserum To Human Immunoglobulins.

Pre-market Notification Details

Device IDK791824
510k NumberK791824
Device Name:ANTISERUM TO HUMAN IMMUNOGLOBULINS
ClassificationIgg, Antigen, Antiserum, Control
Applicant ICL SCIENTIFIC 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeDEW  
CFR Regulation Number866.5510 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1979-09-14
Decision Date1979-10-17

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.