FDA Product Code LCX: Kit, Test, Pregnancy, Hcg, Over The Counter
Leading manufacturers include ACON Laboratories, Inc. and Andon Health Co, Ltd..
2
Total
2
Cleared
244d
Avg days
2024
Since
List of Kit, Test, Pregnancy, Hcg, Over The Counter devices cleared through 510(k)
2 devices
Cleared
Dec 20, 2024
iHealth® Early Pregnancy Test
Andon Health Co, Ltd.
Chemistry
218d
Cleared
May 31, 2024
Distinct® Digital Pregnancy Test
ACON Laboratories, Inc.
Chemistry
269d
How to use this database
This page lists all FDA 510(k) submissions for Kit, Test, Pregnancy, Hcg, Over The Counter devices (product code LCX). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Chemistry FDA review panel. Browse all Chemistry devices →