BIOTIS MARTIN LEWIS AGAR

Culture Media, For Isolation Of Pathogenic Neisseria

OTISVILLE BIOTECH, INC.

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

Pre-market Notification Details

Device IDK843817
510k NumberK843817
Device Name:BIOTIS MARTIN LEWIS AGAR
ClassificationCulture Media, For Isolation Of Pathogenic Neisseria
Applicant OTISVILLE BIOTECH, INC. P.O. BOX 567 Otisville ,  NY  10963 -
ContactErnest M Green
CorrespondentErnest M Green
OTISVILLE BIOTECH, INC. P.O. BOX 567 Otisville ,  NY  10963 -
Product CodeJTY  
CFR Regulation Number866.2410 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-09-28
Decision Date1984-10-10

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