MARTIN LEWIS AGAR (JEMBEC)

Culture Media, For Isolation Of Pathogenic Neisseria

GRANITE DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Granite Diagnostics, Inc. with the FDA for Martin Lewis Agar (jembec).

Pre-market Notification Details

Device IDK771870
510k NumberK771870
Device Name:MARTIN LEWIS AGAR (JEMBEC)
ClassificationCulture Media, For Isolation Of Pathogenic Neisseria
Applicant GRANITE DIAGNOSTICS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeJTY  
CFR Regulation Number866.2410 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1977-10-04
Decision Date1977-10-25

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