DERMATOPHYTE TEST MEDIUM

Culture Media, Selective And Differential

HARDY MEDIA

The following data is part of a premarket notification filed by Hardy Media with the FDA for Dermatophyte Test Medium.

Pre-market Notification Details

Device IDK880132
510k NumberK880132
Device Name:DERMATOPHYTE TEST MEDIUM
ClassificationCulture Media, Selective And Differential
Applicant HARDY MEDIA 205 W.MONTECITO ST. Santa Barbara,  CA  93101
ContactJay Hardy
CorrespondentJay Hardy
HARDY MEDIA 205 W.MONTECITO ST. Santa Barbara,  CA  93101
Product CodeJSI  
CFR Regulation Number866.2360 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-01-06
Decision Date1988-03-30

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