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 W.H.P.M., Inc..
6
Total
6
Cleared
318d
Avg days
2004
Since
Declining activity -
0 submissions in the last 2 years
vs 1 in the prior period
FDA 510(k) Cleared Automated Occult Blood Analyzer Devices (Product Code OOX)
6 devices
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 declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.
OOX devices are reviewed by the Hematology panel. Browse all Hematology devices →