QM300 IGA, ANTIGEN, ANTISERUM, CONTROL

Iga, 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 Iga, Antigen, Antiserum, Control.

Pre-market Notification Details

Device IDK871940
510k NumberK871940
Device Name:QM300 IGA, ANTIGEN, ANTISERUM, CONTROL
ClassificationIga, Antigen, Antiserum, Control
Applicant KALLESTAD DIAG, A DIV. OF ERBAMONT, INC. 2000 LAKE HAZELTINE DR. Chaska,  MN  55318
ContactJan Petersen
CorrespondentJan Petersen
KALLESTAD DIAG, A DIV. OF ERBAMONT, INC. 2000 LAKE HAZELTINE DR. Chaska,  MN  55318
Product CodeCZP  
CFR Regulation Number866.5510 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-05-18
Decision Date1987-06-12

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