ANDRADES FERMENTATION MEDIA

Culture Media, Single Biochemical Test

GRANITE DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Granite Diagnostics, Inc. with the FDA for Andrades Fermentation Media.

Pre-market Notification Details

Device IDK822995
510k NumberK822995
Device Name:ANDRADES FERMENTATION MEDIA
ClassificationCulture Media, Single Biochemical Test
Applicant GRANITE DIAGNOSTICS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeJSF  
CFR Regulation Number866.2320 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-10-12
Decision Date1982-11-16

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