WILKENS CHALGREN AGAR

Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar

ACUMEDIA MANUFACTURERS, INC.

The following data is part of a premarket notification filed by Acumedia Manufacturers, Inc. with the FDA for Wilkens Chalgren Agar.

Pre-market Notification Details

Device IDK881567
510k NumberK881567
Device Name:WILKENS CHALGREN AGAR
ClassificationCulture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
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 CodeJSO  
CFR Regulation Number866.1700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-04-11
Decision Date1988-04-18

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