510(k) K132167
K132167 is an FDA 510(k) premarket notification submitted by Boditech Med, Inc. for the device "I-CHROMA IFOB WITH I-CHROMA READER". The FDA issued a decision of Substantially Equivalent on May 2, 2014. The device falls under product code OOX (Automated Occult Blood Analyzer), a Class II device regulated under 21 CFR 864.6550. Boditech Med, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 2, 2014
- Date Received
- July 12, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
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.