ANTIBIOTIC ASSAY BROTH

Culture Media, Antibiotic Assay

ACUMEDIA MANUFACTURERS, INC.

The following data is part of a premarket notification filed by Acumedia Manufacturers, Inc. with the FDA for Antibiotic Assay Broth.

Pre-market Notification Details

Device IDK832575
510k NumberK832575
Device Name:ANTIBIOTIC ASSAY BROTH
ClassificationCulture Media, Antibiotic Assay
Applicant ACUMEDIA MANUFACTURERS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeJSA  
CFR Regulation Number866.2350 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-08-02
Decision Date1983-09-12

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