FDA Product Code OOX: Automated Occult Blood Analyzer
The Automated Test System Is Intended For The Qualitative Detection Of Fecal Occult Blood In Feces By Professional Laboratories. The Automated Test Is Used For The Determination Of Gastrointestinal Bleeding.
Leading manufacturers include Eiken Chemical Co., Ltd., W.H.P.M., Inc. and Polymedco, Inc..
6
Total
6
Cleared
318d
Avg days
2004
Since
Stable submission activity - 0 submissions in the last 2 years
FDA 510(k) Cleared Automated Occult Blood Analyzer Devices (Product Code OOX)
6 devices
Cleared
Jun 02, 2022
Hemosure Accu-Reader A100
W.H.P.M., Inc.
Hematology
801d
Cleared
Jan 02, 2020
OC-Auto SENSOR io iFOB Test
Eiken Chemical Co., Ltd.
Hematology
247d
Cleared
Aug 08, 2017
AFIAS iFOB with AFIAS-50
Immunostics Inc.,
Hematology
264d
Cleared
May 02, 2014
I-CHROMA IFOB WITH I-CHROMA READER
Boditech Med, Inc.
Hematology
294d
Cleared
Jan 08, 2010
OC-SENSOR DIANA IFOB TEST
Polymedco Cancer Diagnostics, LLC
Hematology
157d
Cleared
Oct 21, 2004
POLYMEDCO OC AUTO MICRO 80 FOB TEST
Polymedco, Inc.
Hematology
147d
About Product Code OOX - Regulatory Context
510(k) Submission Activity
6 total 510(k) submissions under product code OOX since 2004, with 6 receiving FDA clearance (average review time: 318 days).
Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.