CONCEP-7-BHCG (EIA)

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 Concep-7-bhcg (eia).

Pre-market Notification Details

Device IDK844153
510k NumberK844153
Device Name:CONCEP-7-BHCG (EIA)
ClassificationVisual, Pregnancy Hcg, Prescription Use
Applicant LEECO DIAGNOSTICS, INC. 21705 EVERGREEN P.O. BOX 5126 Southfield,  MI  48075
ContactJames P Lee
CorrespondentJames P Lee
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 Received1984-10-24
Decision Date1984-12-14

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