BIOTIS HAEMOPHILUS IDENTIFICATION QUAD

Culture Media, Non-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 Haemophilus Identification Quad.

Pre-market Notification Details

Device IDK862387
510k NumberK862387
Device Name:BIOTIS HAEMOPHILUS IDENTIFICATION QUAD
ClassificationCulture Media, Non-selective And 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 CodeJSH  
CFR Regulation Number866.2320 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-06-24
Decision Date1986-07-03

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