ZEUS SCIENTIFIC INC., TPO 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 Zeus Scientific Inc., Tpo Igg Elisa Test System..

Pre-market Notification Details

Device IDK991610
510k NumberK991610
Device Name:ZEUS SCIENTIFIC INC., TPO IGG ELISA TEST SYSTEM.
ClassificationThyroglobulin, Antigen, Antiserum, Control
Applicant ZEUS SCIENTIFIC, INC. 200 EVANS WAY Branchburg,  NJ  08876
ContactMark J Kopnitsky
CorrespondentMark J Kopnitsky
ZEUS SCIENTIFIC, INC. 200 EVANS WAY Branchburg,  NJ  08876
Product CodeDDC  
CFR Regulation Number866.5870 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-05-10
Decision Date1999-06-25

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00840239027917 K991610 000
04048474027914 K991610 000

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