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 IDK792308
510k NumberK792308
Device Name:CONCEP-7-BHCG
ClassificationVisual, Pregnancy Hcg, Prescription Use
Applicant LEECO DIAGNOSTICS, INC. 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeJHI  
CFR Regulation Number862.1155 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1979-11-16
Decision Date1979-12-06

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