NDS THEOPHYLLINE TEST KIT & NDS TDM CALIBRATOR SET

Enzyme Immunoassay, Theophylline

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 Theophylline Test Kit & Nds Tdm Calibrator Set.

Pre-market Notification Details

Device IDK900009
510k NumberK900009
Device Name:NDS THEOPHYLLINE TEST KIT & NDS TDM CALIBRATOR SET
ClassificationEnzyme Immunoassay, Theophylline
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 CodeKLS  
CFR Regulation Number862.3880 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-01-02
Decision Date1990-03-29

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