BLASTOMYCES/ANTIGEN FOR IMMUNODIFUSION

Antigen, Cf, B. Dermatitidis

MERIDIAN DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Meridian Diagnostics, Inc. with the FDA for Blastomyces/antigen For Immunodifusion.

Pre-market Notification Details

Device IDK792683
510k NumberK792683
Device Name:BLASTOMYCES/ANTIGEN FOR IMMUNODIFUSION
ClassificationAntigen, Cf, B. Dermatitidis
Applicant MERIDIAN DIAGNOSTICS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeJWW  
CFR Regulation Number866.3060 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1979-12-27
Decision Date1980-01-23

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