LEECO PREVIEW(R) EBV (EIA)

System, Test, Infectious Mononucleosis

LEECO DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Leeco Diagnostics, Inc. with the FDA for Leeco Preview(r) Ebv (eia).

Pre-market Notification Details

Device IDK895765
510k NumberK895765
Device Name:LEECO PREVIEW(R) EBV (EIA)
ClassificationSystem, Test, Infectious Mononucleosis
Applicant LEECO DIAGNOSTICS, INC. 24475 WEST TEN MILE RD. Southfield,  MI  48034
ContactDante J Capaldi,phd
CorrespondentDante J Capaldi,phd
LEECO DIAGNOSTICS, INC. 24475 WEST TEN MILE RD. Southfield,  MI  48034
Product CodeKTN  
CFR Regulation Number866.5640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-09-26
Decision Date1989-10-31

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