BIOTIS SCHAEDLER AGAR & BROTH

Culture Media, Non-selective And Non-differential

OTISVILLE BIOTECH, INC.

The following data is part of a premarket notification filed by Otisville Biotech, Inc. with the FDA for Biotis Schaedler Agar & Broth.

Pre-market Notification Details

Device IDK843764
510k NumberK843764
Device Name:BIOTIS SCHAEDLER AGAR & BROTH
ClassificationCulture Media, Non-selective And Non-differential
Applicant OTISVILLE BIOTECH, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeJSG  
CFR Regulation Number866.2300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-09-25
Decision Date1984-10-10

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