RPMI 1640-ROSWELL PARK MEMORIAL INSTITUTE 1640

Media And Components, Synthetic Cell And Tissue Culture

MEDIATECH, INC.

The following data is part of a premarket notification filed by Mediatech, Inc. with the FDA for Rpmi 1640-roswell Park Memorial Institute 1640.

Pre-market Notification Details

Device IDK850513
510k NumberK850513
Device Name:RPMI 1640-ROSWELL PARK MEMORIAL INSTITUTE 1640
ClassificationMedia And Components, Synthetic Cell And Tissue Culture
Applicant MEDIATECH, INC. EDWARD J. MILLER 1090 VERMONT AVE., NW #1200 Washington,  DC  20005
ContactHargrave, Dev
CorrespondentHargrave, Dev
MEDIATECH, INC. EDWARD J. MILLER 1090 VERMONT AVE., NW #1200 Washington,  DC  20005
Product CodeKIT  
CFR Regulation Number864.2220 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-02-08
Decision Date1985-02-27

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