LEECO PREGNASTICK (EIA) CATALOG #003

Kit, Test, Pregnancy, Hcg, Over The Counter

LEECO DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Leeco Diagnostics, Inc. with the FDA for Leeco Pregnastick (eia) Catalog #003.

Pre-market Notification Details

Device IDK880069
510k NumberK880069
Device Name:LEECO PREGNASTICK (EIA) CATALOG #003
ClassificationKit, Test, Pregnancy, Hcg, Over The Counter
Applicant LEECO DIAGNOSTICS, INC. 21705 EVERGREEN P.O. BOX 5126 Southfield,  MI  48075
ContactLee, Phd
CorrespondentLee, Phd
LEECO DIAGNOSTICS, INC. 21705 EVERGREEN P.O. BOX 5126 Southfield,  MI  48075
Product CodeLCX  
CFR Regulation Number862.1155 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-01-11
Decision Date1988-02-11

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