HELICOBACTER PYLORI IGG ELISA TEST SYSTEM

Helicobacter Pylori

ZEUS SCIENTIFIC, INC.

The following data is part of a premarket notification filed by Zeus Scientific, Inc. with the FDA for Helicobacter Pylori Igg Elisa Test System.

Pre-market Notification Details

Device IDK980821
510k NumberK980821
Device Name:HELICOBACTER PYLORI IGG ELISA TEST SYSTEM
ClassificationHelicobacter Pylori
Applicant ZEUS SCIENTIFIC, INC. P.O. BOX 38 Raritan,  NJ  08869
ContactMark J Kopnitsky
CorrespondentMark J Kopnitsky
ZEUS SCIENTIFIC, INC. P.O. BOX 38 Raritan,  NJ  08869
Product CodeLYR  
CFR Regulation Number866.3110 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-03-03
Decision Date1998-07-30

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