VIS-DISK HCG (EIA) JPL-041M

System, Test, Human Chorionic Gonadotropin

LEECO DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Leeco Diagnostics, Inc. with the FDA for Vis-disk Hcg (eia) Jpl-041m.

Pre-market Notification Details

Device IDK891096
510k NumberK891096
Device Name:VIS-DISK HCG (EIA) JPL-041M
ClassificationSystem, Test, Human Chorionic Gonadotropin
Applicant LEECO DIAGNOSTICS, INC. 21705 EVERGREEN P.O. BOX 5126 Southfield,  MI  48075
ContactCapaldi Phd
CorrespondentCapaldi Phd
LEECO DIAGNOSTICS, INC. 21705 EVERGREEN P.O. BOX 5126 Southfield,  MI  48075
Product CodeDHA  
CFR Regulation Number862.1155 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-03-02
Decision Date1989-06-16

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