CLOSTRIDIUM DIFFICILE AGAR DEEP &

Culture Media, Selective And Differential

REMEL CO.

The following data is part of a premarket notification filed by Remel Co. with the FDA for Clostridium Difficile Agar Deep &.

Pre-market Notification Details

Device IDK840889
510k NumberK840889
Device Name:CLOSTRIDIUM DIFFICILE AGAR DEEP &
ClassificationCulture Media, Selective And Differential
Applicant REMEL CO. 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 Received1984-02-27
Decision Date1984-03-23

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