STREPTOCOCCUS ID TRIPLATE SYSTEM

Culture Media, Selective And Differential

GRANITE DIAGNOSTICS, INC.

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

Pre-market Notification Details

Device IDK833254
510k NumberK833254
Device Name:STREPTOCOCCUS ID TRIPLATE SYSTEM
ClassificationCulture Media, Selective And Differential
Applicant GRANITE DIAGNOSTICS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeJSI  
CFR Regulation Number866.2360 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-09-20
Decision Date1983-10-28

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