KALLESTAD SM/RNP TEST REAGENT

Antinuclear Antibody, Antigen, Control

KALLESTAD LABORATORIES, INC.

The following data is part of a premarket notification filed by Kallestad Laboratories, Inc. with the FDA for Kallestad Sm/rnp Test Reagent.

Pre-market Notification Details

Device IDK862313
510k NumberK862313
Device Name:KALLESTAD SM/RNP TEST REAGENT
ClassificationAntinuclear Antibody, Antigen, Control
Applicant KALLESTAD LABORATORIES, INC. 1000 LAKE HAZELTINE DR. Chaska,  MN  55318
ContactKatia Breslawec
CorrespondentKatia Breslawec
KALLESTAD LABORATORIES, INC. 1000 LAKE HAZELTINE DR. Chaska,  MN  55318
Product CodeLKJ  
CFR Regulation Number866.5100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-06-18
Decision Date1986-08-06

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