Recognized a 510(k)/PMA number — showing its clearance record and devices.
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| ForSure iFOB Test Set | 10210 | SYNTRON BIORESEARCH, INC. | KHE | 00748349000021 |
| Accutest iFOBT - Dual Sample Fecal Occult Blood Test | CS612 | JANT PHARMACAL CORPORATION | KHE | 10763924612250 |
| Accutest iFOB Positive and Negative Hemoglobin Controls | CSC67 | JANT PHARMACAL CORPORATION | KHE | 10763924607058 |
| Accutest iFOBT - Specimen Collection Tubes | CS630 | JANT PHARMACAL CORPORATION | KHE | 10763924630551 |
| Accutest iFOBT - Specimen Collection Kit | CS620 | JANT PHARMACAL CORPORATION | KHE | 10763924620552 |
| ForSure iFOB Test (buffer only) | 10210 | SYNTRON BIORESEARCH, INC. | KHE | 00748349000083 |
| Accutest iFOBT - Dual Sample Specimen Collection Kits | CS632 | JANT PHARMACAL CORPORATION | KHE | 10763924632500 |
| Accutest iFOBT - Single Sample Immunological Fecal Occult Blood Test | CS625 | JANT PHARMACAL CORPORATION | KHE | 10763924625250 |
| ForSure iFOB Test (cassette only) | 10210 | SYNTRON BIORESEARCH, INC. | KHE | 00748349000076 |