PROSPECT SHIGA TOXIN MICROPLATE ASSAY

Antigens, All Types, Escherichia Coli

ALEXON - TREND, INC.

The following data is part of a premarket notification filed by Alexon - Trend, Inc. with the FDA for Prospect Shiga Toxin Microplate Assay.

Pre-market Notification Details

Device IDK980507
510k NumberK980507
Device Name:PROSPECT SHIGA TOXIN MICROPLATE ASSAY
ClassificationAntigens, All Types, Escherichia Coli
Applicant ALEXON - TREND, INC. 14000 UNITY ST., N.W. Ramsey,  MN  55303 -9115
ContactBarbara A Chiponis, Mt (ascp)
CorrespondentBarbara A Chiponis, Mt (ascp)
ALEXON - TREND, INC. 14000 UNITY ST., N.W. Ramsey,  MN  55303 -9115
Product CodeGMZ  
CFR Regulation Number866.3255 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-02-10
Decision Date1998-04-23

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05056080501949 K980507 000
05056080501932 K980507 000
05056080501673 K980507 000

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