THE WELLCOME ROTAVIRUS LATEX TEST ZL40

Enzyme Linked Immunoabsorbent Assay, Rotavirus

WELLCOME DIAGNOSTICS

The following data is part of a premarket notification filed by Wellcome Diagnostics with the FDA for The Wellcome Rotavirus Latex Test Zl40.

Pre-market Notification Details

Device IDK861634
510k NumberK861634
Device Name:THE WELLCOME ROTAVIRUS LATEX TEST ZL40
ClassificationEnzyme Linked Immunoabsorbent Assay, Rotavirus
Applicant WELLCOME DIAGNOSTICS 3030 CORNWALLIS RD. Research Triangle Park,  NC  27709
ContactMax D Moodly
CorrespondentMax D Moodly
WELLCOME DIAGNOSTICS 3030 CORNWALLIS RD. Research Triangle Park,  NC  27709
Product CodeLIQ  
CFR Regulation Number866.3405 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-04-29
Decision Date1986-10-29

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