AUTOMATED IMMUNOPRECIPITIN METHOD/ICG

Igg (gamma Chain Specific), Antigen, Antiserum, Control

ICL SCIENTIFIC

The following data is part of a premarket notification filed by Icl Scientific with the FDA for Automated Immunoprecipitin Method/icg.

Pre-market Notification Details

Device IDK803272
510k NumberK803272
Device Name:AUTOMATED IMMUNOPRECIPITIN METHOD/ICG
ClassificationIgg (gamma Chain Specific), Antigen, Antiserum, Control
Applicant ICL SCIENTIFIC 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeDFZ  
CFR Regulation Number866.5510 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1980-12-29
Decision Date1981-01-26

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.