K163225 is an FDA 510(k) clearance for the AFIAS iFOB with AFIAS-50. This device is classified as a Automated Occult Blood Analyzer (Class II - Special Controls, product code OOX).
Submitted by Immunostics Inc., (Ocean, US). The FDA issued a Cleared decision on August 8, 2017, 264 days after receiving the submission on November 17, 2016.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.6550. 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..
| 510(k) Number | K163225 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 17, 2016 |
| Decision Date | August 08, 2017 |
| Days to Decision | 264 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
| Product Code | OOX - Automated Occult Blood Analyzer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.6550 |
| Definition | 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. |