CARBON DIOXIDE REAGENTS

Phenolphthalein Colorimetry, Carbon-dioxide

GAMMA ENTERPRISES, INC.

The following data is part of a premarket notification filed by Gamma Enterprises, Inc. with the FDA for Carbon Dioxide Reagents.

Pre-market Notification Details

Device IDK780506
510k NumberK780506
Device Name:CARBON DIOXIDE REAGENTS
ClassificationPhenolphthalein Colorimetry, Carbon-dioxide
Applicant GAMMA ENTERPRISES, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeKMS  
CFR Regulation Number862.1160 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1978-03-30
Decision Date1978-05-03

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