BIOTIS KV LAKED BLOOD AGAR

Culture Media, 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 Kv Laked Blood Agar.

Pre-market Notification Details

Device IDK862400
510k NumberK862400
Device Name:BIOTIS KV LAKED BLOOD AGAR
ClassificationCulture Media, Selective And Non-differential
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 CodeJSJ  
CFR Regulation Number866.2360 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-06-24
Decision Date1986-07-03

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.