510(k) K163225
K163225 is an FDA 510(k) premarket notification submitted by Immunostics Inc., for the device "AFIAS iFOB with AFIAS-50". The FDA issued a decision of Substantially Equivalent on August 8, 2017. The device falls under product code OOX (Automated Occult Blood Analyzer), a Class II device regulated under 21 CFR 864.6550. Immunostics Inc., has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 8, 2017
- Date Received
- November 17, 2016
- 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.