MODIFICATION TO ZEUS SCIENTIFIC, INC., THYROGLOBULIN IGG ELISA TEST SYSTEM

Thyroglobulin, Antigen, Antiserum, Control

ZEUS SCIENTIFIC, INC.

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

Pre-market Notification Details

Device IDK000363
510k NumberK000363
Device Name:MODIFICATION TO ZEUS SCIENTIFIC, INC., THYROGLOBULIN IGG ELISA TEST SYSTEM
ClassificationThyroglobulin, Antigen, Antiserum, Control
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 CodeDDC  
CFR Regulation Number866.5870 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-02-04
Decision Date2000-02-18

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