FDA Product Code KHE: Reagent, Occult Blood
Leading manufacturers include Guangzhou Wondfo Biotech Co., Ltd. and Alfa Scientific Designs, Inc..
2
Total
2
Cleared
201d
Avg days
2017
Since
List of Reagent, Occult Blood devices cleared through 510(k)
2 devices
Cleared
Feb 15, 2018
Instant-view-PLUS immunochemical Fecal Occult Blood Test
Alfa Scientific Designs, Inc.
Hematology
136d
Cleared
May 14, 2017
Wondfo One Step Fecal Occult Blood (FOB) Test
Guangzhou Wondfo Biotech Co., Ltd.
Hematology
265d
How to use this database
This page lists all FDA 510(k) submissions for Reagent, Occult Blood devices (product code KHE). 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 Hematology FDA review panel. Browse all Hematology devices →