NDS THYROXINE TEST KIT & NDS THYROXINE CALIBRATOR

Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine

KALLESTAD DIAG, A DIV. OF ERBAMONT, INC.

The following data is part of a premarket notification filed by Kallestad Diag, A Div. Of Erbamont, Inc. with the FDA for Nds Thyroxine Test Kit & Nds Thyroxine Calibrator.

Pre-market Notification Details

Device IDK897072
510k NumberK897072
Device Name:NDS THYROXINE TEST KIT & NDS THYROXINE CALIBRATOR
ClassificationEnzyme Immunoassay, Non-radiolabeled, Total Thyroxine
Applicant KALLESTAD DIAG, A DIV. OF ERBAMONT, INC. 2000 LAKE HAZELTINE DR. Chaska,  MN  55318
ContactJan Olsen
CorrespondentJan Olsen
KALLESTAD DIAG, A DIV. OF ERBAMONT, INC. 2000 LAKE HAZELTINE DR. Chaska,  MN  55318
Product CodeKLI  
CFR Regulation Number862.1700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-12-22
Decision Date1990-03-29

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