TRANSPORT MEDIUM AMIES

Culture Media, Non-propagating Transport

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 Transport Medium Amies.

Pre-market Notification Details

Device IDK791545
510k NumberK791545
Device Name:TRANSPORT MEDIUM AMIES
ClassificationCulture Media, Non-propagating Transport
Applicant ISLE MEDIA AND STERILE PRODUCTS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeJSM  
CFR Regulation Number866.2390 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1979-08-10
Decision Date1979-09-17

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