STAPHYLOCOCCUS MED. 110

Culture Media, Selective And Non-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 Staphylococcus Med. 110.

Pre-market Notification Details

Device IDK800156
510k NumberK800156
Device Name:STAPHYLOCOCCUS MED. 110
ClassificationCulture Media, Selective And Non-differential
Applicant ISLE MEDIA AND STERILE PRODUCTS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeJSJ  
CFR Regulation Number866.2360 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1980-01-24
Decision Date1980-02-13

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