KHE · Class II · 21 CFR 864.6550

FDA Product Code KHE: Reagent, Occult Blood

Leading manufacturers include Helena Laboratories, Roche Diagnostics Corp. and Beckman Coulter, Inc..

Total

Cleared

135d

Avg days

1976

Since

FDA 510(k) Cleared Reagent, Occult Blood Devices (Product Code KHE)

97 devices

1–24 of 97

Cleared Feb 15, 2018

Instant-view-PLUS immunochemical Fecal Occult Blood Test

K173212

Alfa Scientific Designs, Inc.

Hematology · 136d

Cleared May 14, 2017

Wondfo One Step Fecal Occult Blood (FOB) Test

K162333

Guangzhou Wondfo Biotech Co., Ltd.

Beckman Coulter, Inc.

Hematology · 93d

Cleared Nov 24, 2003

ROCHE DIAGNOSTICS URISYS 1100 URINE ANALYZER

K033548

Roche Diagnostics Corp.

HELENA COLOSCREEN SELF-TEST

HELENA COLOSCREEN METHOD

Boehringer Mannheim Corp.

Hematology · 84d

FDA Product Code KHE: Reagent, Occult Blood

FDA 510(k) Cleared Reagent, Occult Blood Devices (Product Code KHE)

About Product Code KHE - Regulatory Context

Related FDA 510(k) Regulatory Insights