PROTEOSE NO. 3 AGAR

Culture Media, For Isolation Of Pathogenic Neisseria

ACUMEDIA MANUFACTURERS, INC.

The following data is part of a premarket notification filed by Acumedia Manufacturers, Inc. with the FDA for Proteose No. 3 Agar.

Pre-market Notification Details

Device IDK881552
510k NumberK881552
Device Name:PROTEOSE NO. 3 AGAR
ClassificationCulture Media, For Isolation Of Pathogenic Neisseria
Applicant ACUMEDIA MANUFACTURERS, INC. 3651 CLIPPER MILL RD. Baltimore,  MD  21211
ContactCunningham, Phd
CorrespondentCunningham, Phd
ACUMEDIA MANUFACTURERS, INC. 3651 CLIPPER MILL RD. Baltimore,  MD  21211
Product CodeJTY  
CFR Regulation Number866.2410 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-04-08
Decision Date1988-04-18

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