EL-ANA PROFILES-2K1

Antinuclear Antibody (enzyme-labeled), Antigen, Controls

THERATEST LABORATORIES, INC.

The following data is part of a premarket notification filed by Theratest Laboratories, Inc. with the FDA for El-ana Profiles-2k1.

Pre-market Notification Details

Device IDK002559
510k NumberK002559
Device Name:EL-ANA PROFILES-2K1
ClassificationAntinuclear Antibody (enzyme-labeled), Antigen, Controls
Applicant THERATEST LABORATORIES, INC. 2201 WEST CAMPBELL PARK DR. Chicago,  IL  60612 -3501
ContactMarius Teodorescu
CorrespondentMarius Teodorescu
THERATEST LABORATORIES, INC. 2201 WEST CAMPBELL PARK DR. Chicago,  IL  60612 -3501
Product CodeLJM  
CFR Regulation Number866.5100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-08-17
Decision Date2000-09-12

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