QM300 IGG ANTIBODY PACK

Igg, 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 Igg Antibody Pack.

Pre-market Notification Details

Device IDK882083
510k NumberK882083
Device Name:QM300 IGG ANTIBODY PACK
ClassificationIgg, Antigen, Antiserum, Control
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 CodeDEW  
CFR Regulation Number866.5510 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-05-18
Decision Date1988-07-08

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