QUANTIMETRIC PLUS IGM REAGENT KIT

Igm, Antigen, Antiserum, Control

KALLESTAD LABORATORIES, INC.

The following data is part of a premarket notification filed by Kallestad Laboratories, Inc. with the FDA for Quantimetric Plus Igm Reagent Kit.

Pre-market Notification Details

Device IDK855010
510k NumberK855010
Device Name:QUANTIMETRIC PLUS IGM REAGENT KIT
ClassificationIgm, Antigen, Antiserum, Control
Applicant KALLESTAD LABORATORIES, INC. 1000 LAKE HAZELTINE DR. Chaska,  MN  55318
ContactQuinlan Smith
CorrespondentQuinlan Smith
KALLESTAD LABORATORIES, INC. 1000 LAKE HAZELTINE DR. Chaska,  MN  55318
Product CodeDFT  
CFR Regulation Number866.5550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-12-16
Decision Date1986-02-28

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