WIELISA ANCA SCREENING KIT TEST SYSTEM

Test System, Antineutrophil Cytoplasmic Antibodies (anca)

WIESLAB AB

The following data is part of a premarket notification filed by Wieslab Ab with the FDA for Wielisa Anca Screening Kit Test System.

Pre-market Notification Details

Device IDK981748
510k NumberK981748
Device Name:WIELISA ANCA SCREENING KIT TEST SYSTEM
ClassificationTest System, Antineutrophil Cytoplasmic Antibodies (anca)
Applicant WIESLAB AB 1306 BAILES LN. SUITE F Frederick,  MD  21701
ContactWilliam L Boteler, Jr.
CorrespondentWilliam L Boteler, Jr.
WIESLAB AB 1306 BAILES LN. SUITE F Frederick,  MD  21701
Product CodeMOB  
CFR Regulation Number866.5660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-05-18
Decision Date1998-07-22
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.