KALLESTAD QM300 CALIBRATOR C PACK

C-reactive Protein, Antigen, Antiserum, And 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 Kallestad Qm300 Calibrator C Pack.

Pre-market Notification Details

Device IDK880729
510k NumberK880729
Device Name:KALLESTAD QM300 CALIBRATOR C PACK
ClassificationC-reactive Protein, Antigen, Antiserum, And 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 CodeDCK  
CFR Regulation Number866.5270 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-02-23
Decision Date1988-03-30

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