| Device Type ID | 2353 |
| Device Name | Blood, Occult, Colorimetric, In Urine |
| Regulation Description | Occult Blood Test. |
| Regulation Medical Specialty | Hematology |
| Review Panel | Hematology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(k) |
| CFR Regulation Number | 864.6550 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | JIO |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
|
| Device Type ID | 2353 |
| Device | Blood, Occult, Colorimetric, In Urine |
| Product Code | JIO |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Occult Blood Test. |
| CFR Regulation Number | 864.6550 [🔎] |
| Device Problems | |
|---|---|
False Negative Result | 1 |
| Total Device Problems | 1 |