CARBON DIOXIDE

Phenolphthalein Colorimetry, Carbon-dioxide

CATACHEM, INC.

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

Pre-market Notification Details

Device IDK872886
510k NumberK872886
Device Name:CARBON DIOXIDE
ClassificationPhenolphthalein Colorimetry, Carbon-dioxide
Applicant CATACHEM, INC. 6 NORTH PEARL ST. Port Chester,  NY  10573
ContactLuis P Leon
CorrespondentLuis P Leon
CATACHEM, INC. 6 NORTH PEARL ST. Port Chester,  NY  10573
Product CodeKMS  
CFR Regulation Number862.1160 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-07-22
Decision Date1987-08-13

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