HAEMOPHILUS ID PLATE

Culture Media, Non-selective And Differential

GRANITE DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Granite Diagnostics, Inc. with the FDA for Haemophilus Id Plate.

Pre-market Notification Details

Device IDK822377
510k NumberK822377
Device Name:HAEMOPHILUS ID PLATE
ClassificationCulture Media, Non-selective And Differential
Applicant GRANITE DIAGNOSTICS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeJSH  
CFR Regulation Number866.2320 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-08-06
Decision Date1982-08-25

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