NEISSERIA GONORRHOEAE FLUORO-KIT

Antiserum, Fluorescent (direct Test), All Groups, N. Gonorrhoeae

CLINICAL SCIENCES, INC.

The following data is part of a premarket notification filed by Clinical Sciences, Inc. with the FDA for Neisseria Gonorrhoeae Fluoro-kit.

Pre-market Notification Details

Device IDK800328
510k NumberK800328
Device Name:NEISSERIA GONORRHOEAE FLUORO-KIT
ClassificationAntiserum, Fluorescent (direct Test), All Groups, N. Gonorrhoeae
Applicant CLINICAL SCIENCES, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeGTH  
CFR Regulation Number866.3390 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1980-02-12
Decision Date1980-03-03

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