DERMATOPHYTIN O

Kit, Identification, Yeast

DIAGNOSTICA, INC.

The following data is part of a premarket notification filed by Diagnostica, Inc. with the FDA for Dermatophytin O.

Pre-market Notification Details

Device IDK790671
510k NumberK790671
Device Name:DERMATOPHYTIN O
ClassificationKit, Identification, Yeast
Applicant DIAGNOSTICA, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeJXB  
CFR Regulation Number866.2660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1979-04-06
Decision Date1979-05-31

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