QM300 CALIBRATOR F PACK

Lipoprotein, Low-density, 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 Calibrator F Pack.

Pre-market Notification Details

Device IDK883711
510k NumberK883711
Device Name:QM300 CALIBRATOR F PACK
ClassificationLipoprotein, Low-density, 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 CodeDFC  
CFR Regulation Number866.5600 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-08-30
Decision Date1988-09-22

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