FDA Product Code
FDA Product Code OOX — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Hematology
- 21 CFR Citation
- 864.6550
510(k) Clearances — 6 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K200754 | Hemosure Accu-Reader A100 | W.H.P.M., Inc. | 2022-06-02 | Traditional | PDF ↗ |
| K191147 | OC-Auto SENSOR io iFOB Test | Eiken Chemical Co., Ltd. | 2020-01-02 | Traditional | PDF ↗ |
| K163225 | AFIAS iFOB with AFIAS-50 | Immunostics Inc., | 2017-08-08 | Traditional | PDF ↗ |
| K132167 | I-CHROMA IFOB WITH I-CHROMA READER | Boditech Med, Inc. | 2014-05-02 | Traditional | PDF ↗ |
| K092330 | OC-SENSOR DIANA IFOB TEST | Polymedco Cancer Diagnostics, LLC | 2010-01-08 | Traditional | PDF ↗ |
| K041408 | POLYMEDCO OC AUTO MICRO 80 FOB TEST | Polymedco, Inc. | 2004-10-21 | Traditional | PDF ↗ |
Product code OOX · Class II · Hematology. Data: openFDA.