CHOCOLATE AGAR GC BASE PLATE

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 Chocolate Agar Gc Base Plate.

Pre-market Notification Details

Device IDK840065
510k NumberK840065
Device Name:CHOCOLATE AGAR GC BASE PLATE
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 Received1984-01-09
Decision Date1984-02-13

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