SCHAEDLER AGARS

Culture Media, Selective And Non-differential

GRANITE DIAGNOSTICS, INC.

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

Pre-market Notification Details

Device IDK823248
510k NumberK823248
Device Name:SCHAEDLER AGARS
ClassificationCulture Media, Selective And Non-differential
Applicant GRANITE DIAGNOSTICS, 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 Received1982-11-01
Decision Date1982-12-03

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