The following data is part of a premarket notification filed by Eiken Chemical Co. Ltd with the FDA for Oc-light S Fit.
| Device ID | K143325 |
| 510k Number | K143325 |
| Device Name: | OC-Light S FIT |
| Classification | Reagent, Occult Blood |
| Applicant | EIKEN CHEMICAL CO. LTD 4-19-9 TAITO Taito-ku, JP 110-8408 |
| Contact | Yoshinori Ota |
| Correspondent | Takashi Enomoto EIKEN CHEMICAL CO. LTD 4-19-9 TAITO Taito-ku, JP 110-8408 |
| Product Code | KHE |
| CFR Regulation Number | 864.6550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-11-20 |
| Decision Date | 2015-08-20 |
| Summary: | summary |