The following data is part of a premarket notification filed by Eiken Chemical Co., Ltd. with the FDA for Oc-sensor Diana Ifob Test.
| Device ID | K092330 |
| 510k Number | K092330 |
| Device Name: | OC-SENSOR DIANA IFOB TEST |
| Classification | Automated Occult Blood Analyzer |
| Applicant | EIKEN CHEMICAL CO., LTD. 4-19-9, TAITO, TAITO-KU Tokyo, JP 110-8408 |
| Product Code | OOX |
| CFR Regulation Number | 864.6550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2009-08-04 |
| Decision Date | 2010-01-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816917022901 | K092330 | 000 |
| 00855574005186 | K092330 | 000 |
| 00855574005179 | K092330 | 000 |
| 00855574005162 | K092330 | 000 |
| 00855574005100 | K092330 | 000 |