FDA Product Code KHE: Reagent, Occult Blood
Leading manufacturers include Guangzhou Wondfo Biotech Co., Ltd. and Alfa Scientific Designs, Inc..
97
Total
97
Cleared
135d
Avg days
1976
Since
FDA 510(k) Cleared Reagent, Occult Blood Devices (Product Code KHE)
97 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
About Product Code KHE - Regulatory Context
KHE devices are reviewed by the Hematology panel. Browse all Hematology devices →