BIOTIS CDC MODIFIED MCCLUNG-TOABE EGG

Culture Media, Enriched

OTISVILLE BIOTECH, INC.

The following data is part of a premarket notification filed by Otisville Biotech, Inc. with the FDA for Biotis Cdc Modified Mcclung-toabe Egg.

Pre-market Notification Details

Device IDK843065
510k NumberK843065
Device Name:BIOTIS CDC MODIFIED MCCLUNG-TOABE EGG
ClassificationCulture Media, Enriched
Applicant OTISVILLE BIOTECH, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeKZI  
CFR Regulation Number866.2330 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-08-06
Decision Date1984-08-20

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