CONCEP-7-BHCG

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.

Pre-market Notification Details

Device IDK880577
510k NumberK880577
Device Name:CONCEP-7-BHCG
ClassificationVisual, Pregnancy Hcg, Prescription Use
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 CodeJHI  
CFR Regulation Number862.1155 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-02-10
Decision Date1988-03-15

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