EARLE'S BALANCED SALTS W/OUT PHENOL RED & SODIUM

Media And Components, Synthetic Cell And Tissue Culture

SIGMA CHEMICAL CO.

The following data is part of a premarket notification filed by Sigma Chemical Co. with the FDA for Earle's Balanced Salts W/out Phenol Red & Sodium.

Pre-market Notification Details

Device IDK880691
510k NumberK880691
Device Name:EARLE'S BALANCED SALTS W/OUT PHENOL RED & SODIUM
ClassificationMedia And Components, Synthetic Cell And Tissue Culture
Applicant SIGMA CHEMICAL CO. P.O. BOX 14508 St. Louis,  MO  63178
ContactDavid Bagley
CorrespondentDavid Bagley
SIGMA CHEMICAL CO. P.O. BOX 14508 St. Louis,  MO  63178
Product CodeKIT  
CFR Regulation Number864.2220 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-02-22
Decision Date1988-03-31

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