GCII AGAR WITH ISOVITALX(R) ENRICHMENT

Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar

BECTON DICKINSON MICROBIOLOGY SYSTEMS

The following data is part of a premarket notification filed by Becton Dickinson Microbiology Systems with the FDA for Gcii Agar With Isovitalx(r) Enrichment.

Pre-market Notification Details

Device IDK945569
510k NumberK945569
Device Name:GCII AGAR WITH ISOVITALX(R) ENRICHMENT
ClassificationCulture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
Applicant BECTON DICKINSON MICROBIOLOGY SYSTEMS P.O. BOX 243 Cockeysville,  MD  21030 -0243
ContactJudith J Smith
CorrespondentJudith J Smith
BECTON DICKINSON MICROBIOLOGY SYSTEMS P.O. BOX 243 Cockeysville,  MD  21030 -0243
Product CodeJSO  
CFR Regulation Number866.1700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-10-11
Decision Date1995-02-02

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