GELMAN IG-FIX KIT

Iga, Antigen, Antiserum, Control

GELMAN SCIENCES, INC.

The following data is part of a premarket notification filed by Gelman Sciences, Inc. with the FDA for Gelman Ig-fix Kit.

Pre-market Notification Details

Device IDK812253
510k NumberK812253
Device Name:GELMAN IG-FIX KIT
ClassificationIga, Antigen, Antiserum, Control
Applicant GELMAN SCIENCES, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeCZP  
CFR Regulation Number866.5510 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-08-11
Decision Date1981-09-01

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