INDIRECT FLUORO-KIT HSV

Antisera, Fluorescent, Herpesvirus Hominis 1,2

CLINICAL SCIENCES, INC.

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

Pre-market Notification Details

Device IDK830623
510k NumberK830623
Device Name:INDIRECT FLUORO-KIT HSV
ClassificationAntisera, Fluorescent, Herpesvirus Hominis 1,2
Applicant CLINICAL SCIENCES, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeGQL  
CFR Regulation Number866.3305 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-02-28
Decision Date1983-07-07

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