MODIFIED QM300 RHEUMATOID FACTOR TEST

System, Test, Rheumatoid Factor

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 Modified Qm300 Rheumatoid Factor Test.

Pre-market Notification Details

Device IDK902462
510k NumberK902462
Device Name:MODIFIED QM300 RHEUMATOID FACTOR TEST
ClassificationSystem, Test, Rheumatoid Factor
Applicant KALLESTAD DIAG, A DIV. OF ERBAMONT, INC. 2000 LAKE HAZELTINE DR. Chaska,  MN  55318
ContactJan Nebelsick
CorrespondentJan Nebelsick
KALLESTAD DIAG, A DIV. OF ERBAMONT, INC. 2000 LAKE HAZELTINE DR. Chaska,  MN  55318
Product CodeDHR  
CFR Regulation Number866.5775 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-06-04
Decision Date1990-06-21

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