The following data is part of a premarket notification filed by Eiken Chemical Co., Ltd. with the FDA for Oc-auto Sensor Io Ifob Test.
| Device ID | K191147 |
| 510k Number | K191147 |
| Device Name: | OC-Auto SENSOR Io IFOB Test |
| Classification | Automated Occult Blood Analyzer |
| Applicant | Eiken Chemical Co., Ltd. 4-19-9, Taito Taito-ku, JP 110-8408 |
| Contact | Tadashi Yasuda |
| Correspondent | Tadashi Yasuda Eiken Chemical Co., Ltd. 4-19-9, Taito Taito-ku, JP 110-8408 |
| Product Code | OOX |
| CFR Regulation Number | 864.6550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-04-30 |
| Decision Date | 2020-01-02 |