SODIUM BICARBONATE (7.5%) SOLUTION

Media And Components, Synthetic Cell And Tissue Culture

DUTCHLAND LABORATORIES, INC.

The following data is part of a premarket notification filed by Dutchland Laboratories, Inc. with the FDA for Sodium Bicarbonate (7.5%) Solution.

Pre-market Notification Details

Device IDK810780
510k NumberK810780
Device Name:SODIUM BICARBONATE (7.5%) SOLUTION
ClassificationMedia And Components, Synthetic Cell And Tissue Culture
Applicant DUTCHLAND LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeKIT  
CFR Regulation Number864.2220 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-03-23
Decision Date1981-05-13

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