NYC-GC MEDIA

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 Nyc-gc Media.

Pre-market Notification Details

Device IDK832948
510k NumberK832948
Device Name:NYC-GC MEDIA
ClassificationCulture Media, For Isolation Of Pathogenic Neisseria
Applicant OTISVILLE BIOTECH, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeJTY  
CFR Regulation Number866.2410 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-08-30
Decision Date1983-09-29

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