QUANTIMETRIC PLUS IGA REAGENT KIT

Iga, 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 Iga Reagent Kit.

Pre-market Notification Details

Device IDK855009
510k NumberK855009
Device Name:QUANTIMETRIC PLUS IGA REAGENT KIT
ClassificationIga, 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 CodeCZP  
CFR Regulation Number866.5510 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-12-16
Decision Date1986-02-26

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