QM300 TRANSFERRIN ANTIBODY PACK

Transferrin, 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 Transferrin Antibody Pack.

Pre-market Notification Details

Device IDK873789
510k NumberK873789
Device Name:QM300 TRANSFERRIN ANTIBODY PACK
ClassificationTransferrin, 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 CodeDDG  
CFR Regulation Number866.5880 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-09-17
Decision Date1987-10-07

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.