SABOURAUD DEXTROSE AGAR

Culture Media, Selective And Non-differential

ACUDERM, INC.

The following data is part of a premarket notification filed by Acuderm, Inc. with the FDA for Sabouraud Dextrose Agar.

Pre-market Notification Details

Device IDK832583
510k NumberK832583
Device Name:SABOURAUD DEXTROSE AGAR
ClassificationCulture Media, Selective And Non-differential
Applicant ACUDERM, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeJSJ  
CFR Regulation Number866.2360 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-08-02
Decision Date1983-09-12

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00814105021224 K832583 000

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