UREA AGAR

Culture Media, Selective And Differential

ISLE MEDIA AND STERILE PRODUCTS, INC.

The following data is part of a premarket notification filed by Isle Media And Sterile Products, Inc. with the FDA for Urea Agar.

Pre-market Notification Details

Device IDK791940
510k NumberK791940
Device Name:UREA AGAR
ClassificationCulture Media, Selective And Differential
Applicant ISLE MEDIA AND STERILE PRODUCTS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeJSI  
CFR Regulation Number866.2360 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1979-10-01
Decision Date1979-10-30

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