QM300 CERULOPLASMIN ANTIBODY PACK

Ceruloplasmin, 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 Ceruloplasmin Antibody Pack.

Pre-market Notification Details

Device IDK895377
510k NumberK895377
Device Name:QM300 CERULOPLASMIN ANTIBODY PACK
ClassificationCeruloplasmin, 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 CodeDDB  
CFR Regulation Number866.5210 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-08-30
Decision Date1989-09-21

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