AIM SYSTEM (FOR IGM)

Igm, Antigen, Antiserum, Control

ICL SCIENTIFIC

The following data is part of a premarket notification filed by Icl Scientific with the FDA for Aim System (for Igm).

Pre-market Notification Details

Device IDK811124
510k NumberK811124
Device Name:AIM SYSTEM (FOR IGM)
ClassificationIgm, Antigen, Antiserum, Control
Applicant ICL SCIENTIFIC 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeDFT  
CFR Regulation Number866.5550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-04-24
Decision Date1981-05-08

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