RADIAL IMMUNODIFFUSION KIT-IMMUNOGLOB.G

Igg, Antigen, Antiserum, Control

GELMAN INSTRUMENT CO.

The following data is part of a premarket notification filed by Gelman Instrument Co. with the FDA for Radial Immunodiffusion Kit-immunoglob.g.

Pre-market Notification Details

Device IDK772077
510k NumberK772077
Device Name:RADIAL IMMUNODIFFUSION KIT-IMMUNOGLOB.G
ClassificationIgg, Antigen, Antiserum, Control
Applicant GELMAN INSTRUMENT CO. 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 Received1977-11-03
Decision Date1978-02-03

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