WELLCOZYME HSV WZO2

Antigen, Cf (including Cf Control), Herpesvirus Hominis 1,2

WELLCOME DIAGNOSTICS

The following data is part of a premarket notification filed by Wellcome Diagnostics with the FDA for Wellcozyme Hsv Wzo2.

Pre-market Notification Details

Device IDK875311
510k NumberK875311
Device Name:WELLCOZYME HSV WZO2
ClassificationAntigen, Cf (including Cf Control), Herpesvirus Hominis 1,2
Applicant WELLCOME DIAGNOSTICS 3030 CORNWALLIS RD. Research Triangle Park,  NC  27709
ContactMoody, Phd
CorrespondentMoody, Phd
WELLCOME DIAGNOSTICS 3030 CORNWALLIS RD. Research Triangle Park,  NC  27709
Product CodeGQN  
CFR Regulation Number866.3305 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-12-29
Decision Date1988-08-03

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