FDA 510(k) Applications for Medical Device Product Code "OOX"
(Automated Occult Blood Analyzer)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K132167 | Boditech Med Inc. | I-CHROMA IFOB WITH I-CHROMA READER | 05/02/2014 |
| K191147 | Eiken Chemical Co., Ltd. | OC-Auto SENSOR io iFOB Test | 01/02/2020 |
| K092330 | EIKEN CHEMICAL CO., LTD. | OC-SENSOR DIANA IFOB TEST | 01/08/2010 |
| K163225 | IMMUNOSTICS, INC. | AFIAS iFOB with AFIAS-50 | 08/08/2017 |
| K041408 | POLYMEDCO, INC. | POLYMEDCO OC AUTO MICRO 80 FOB TEST | 10/21/2004 |
| K200754 | W.H.P.M., Inc | Hemosure Accu-Reader A100 | 06/02/2022 |
Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact
