CANDIDA ALBICANS, ANTIGEN

Antigen, Cf And / Or Id, Coccidioides Immitis

MERIDIAN DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Meridian Diagnostics, Inc. with the FDA for Candida Albicans, Antigen.

Pre-market Notification Details

Device IDK792716
510k NumberK792716
Device Name:CANDIDA ALBICANS, ANTIGEN
ClassificationAntigen, Cf And / Or Id, Coccidioides Immitis
Applicant MERIDIAN DIAGNOSTICS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeGMI  
CFR Regulation Number866.3135 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1979-12-27
Decision Date1980-01-24

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.