VIS-CUBE HCG (EIA) LYOPHILIZED JPL-044

Visual, Pregnancy Hcg, Prescription Use

LEECO DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Leeco Diagnostics, Inc. with the FDA for Vis-cube Hcg (eia) Lyophilized Jpl-044.

Pre-market Notification Details

Device IDK870259
510k NumberK870259
Device Name:VIS-CUBE HCG (EIA) LYOPHILIZED JPL-044
ClassificationVisual, Pregnancy Hcg, Prescription Use
Applicant LEECO DIAGNOSTICS, INC. 21705 EVERGREEN P.O. BOX 5126 Southfield,  MI  48075
ContactLee, Ph.d.
CorrespondentLee, Ph.d.
LEECO DIAGNOSTICS, INC. 21705 EVERGREEN P.O. BOX 5126 Southfield,  MI  48075
Product CodeJHI  
CFR Regulation Number862.1155 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-01-23
Decision Date1987-03-10

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