510(k) K092330
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 8, 2010
- Date Received
- August 4, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Automated Occult Blood Analyzer
- Device Class
- Class II
- Regulation Number
- 864.6550
- Review Panel
- HE
- Submission Type
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.