KALLESTAD QUANTAFLUOR ANTITHYROID ANTIBODY TEST

System, Test, Thyroid Autoantibody

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 Quantafluor Antithyroid Antibody Test.

Pre-market Notification Details

Device IDK881933
510k NumberK881933
Device Name:KALLESTAD QUANTAFLUOR ANTITHYROID ANTIBODY TEST
ClassificationSystem, Test, Thyroid Autoantibody
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 CodeJZO  
CFR Regulation Number866.5870 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-05-10
Decision Date1988-06-06

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