CARBON DIOXIDE REAGENT

Enzymatic, Carbon-dioxide

INTERSECT SYSTEMS, INC.

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

Pre-market Notification Details

Device IDK881169
510k NumberK881169
Device Name:CARBON DIOXIDE REAGENT
ClassificationEnzymatic, Carbon-dioxide
Applicant INTERSECT SYSTEMS, INC. 1606 E. KESSLER BLVD., #100 P.O. BOX 889 Longview,  WA  98632
ContactLester B Garrison
CorrespondentLester B Garrison
INTERSECT SYSTEMS, INC. 1606 E. KESSLER BLVD., #100 P.O. BOX 889 Longview,  WA  98632
Product CodeKHS  
CFR Regulation Number862.1160 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-03-18
Decision Date1988-04-28

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.