QM300 ALPHA1-ACID GLYCOPROTEIN ANTIBODY PACK

Fc, Antigen, Antiserum, Control

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 Qm300 Alpha1-acid Glycoprotein Antibody Pack.

Pre-market Notification Details

Device IDK894538
510k NumberK894538
Device Name:QM300 ALPHA1-ACID GLYCOPROTEIN ANTIBODY PACK
ClassificationFc, Antigen, Antiserum, Control
Applicant KALLESTAD DIAG, A DIV. OF ERBAMONT, INC. 2000 LAKE HAZELTINE DR. Chaska,  MN  55318
ContactJan Nebelsick
CorrespondentJan Nebelsick
KALLESTAD DIAG, A DIV. OF ERBAMONT, INC. 2000 LAKE HAZELTINE DR. Chaska,  MN  55318
Product CodeDBN  
CFR Regulation Number866.5530 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-07-20
Decision Date1989-08-04

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