BIOTIS TSI

Culture Media, Multiple Biochemical Test

OTISVILLE BIOTECH, INC.

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

Pre-market Notification Details

Device IDK860413
510k NumberK860413
Device Name:BIOTIS TSI
ClassificationCulture Media, Multiple Biochemical Test
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 CodeJSE  
CFR Regulation Number866.2320 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-02-03
Decision Date1986-02-24

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