RADIAL IMMUNODIFFUSION KIT-ALPH-L-ANTIT

Alpha-1-antitrypsin, 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-alph-l-antit.

Pre-market Notification Details

Device IDK772080
510k NumberK772080
Device Name:RADIAL IMMUNODIFFUSION KIT-ALPH-L-ANTIT
ClassificationAlpha-1-antitrypsin, Antigen, Antiserum, Control
Applicant GELMAN INSTRUMENT CO. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeDEM  
CFR Regulation Number866.5130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1977-11-03
Decision Date1978-02-03

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