SFP AGAR PLATES

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 Sfp Agar Plates.

Pre-market Notification Details

Device IDK834424
510k NumberK834424
Device Name:SFP AGAR PLATES
ClassificationCulture Media, Selective And Non-differential
Applicant OTISVILLE BIOTECH, INC. 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeJSJ  
CFR Regulation Number866.2360 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-12-15
Decision Date1984-10-23

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