510(k) K092330
K092330 is an FDA 510(k) premarket notification submitted by Polymedco Cancer Diagnostics, LLC for the device "OC-SENSOR DIANA IFOB TEST". The FDA issued a decision of Substantially Equivalent on January 8, 2010. The device falls under product code OOX (Automated Occult Blood Analyzer), a Class II device regulated under 21 CFR 864.6550.
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.