QM2/QM300 CONTROL B PACK

Alpha-1-antitrypsin, 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 Qm2/qm300 Control B Pack.

Pre-market Notification Details

Device IDK875283
510k NumberK875283
Device Name:QM2/QM300 CONTROL B PACK
ClassificationAlpha-1-antitrypsin, 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 CodeDEM  
CFR Regulation Number866.5130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-12-24
Decision Date1988-02-10

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