K191147 is an FDA 510(k) clearance for the OC-Auto SENSOR io iFOB Test. This device is classified as a Automated Occult Blood Analyzer (Class II - Special Controls, product code OOX).
Submitted by Eiken Chemical Co., Ltd. (Taito-Ku, JP). The FDA issued a Cleared decision on January 2, 2020, 247 days after receiving the submission on April 30, 2019.
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 | K191147 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 30, 2019 |
| Decision Date | January 02, 2020 |
| Days to Decision | 247 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. |