BIOTIS EMB AGAR HOLT-HARRIS

Culture Media, Selective And Differential

OTISVILLE BIOTECH, INC.

The following data is part of a premarket notification filed by Otisville Biotech, Inc. with the FDA for Biotis Emb Agar Holt-harris.

Pre-market Notification Details

Device IDK843763
510k NumberK843763
Device Name:BIOTIS EMB AGAR HOLT-HARRIS
ClassificationCulture Media, Selective And Differential
Applicant OTISVILLE BIOTECH, INC. 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 Received1984-09-25
Decision Date1984-10-10

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