BIOTIS LOWENSTEIN-JENSEN MEDIA

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 Lowenstein-jensen Media.

Pre-market Notification Details

Device IDK843769
510k NumberK843769
Device Name:BIOTIS LOWENSTEIN-JENSEN MEDIA
ClassificationCulture Media, Non-selective And Differential
Applicant OTISVILLE BIOTECH, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeJSH  
CFR Regulation Number866.2320 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-09-25
Decision Date1984-10-10

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