| Device Type ID | 2375 |
| Device Name | Reagent, Occult Blood |
| 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 | KHE |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 2375 |
| Device | Reagent, Occult Blood |
| Product Code | KHE |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Occult Blood Test. |
| CFR Regulation Number | 864.6550 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ALFA SCIENTIFIC DESIGNS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CLINICAL GENOMICS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
GUANGZHOU WONDFO BIOTECH CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
IMMUNOSTICS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
| Device Problems | |
|---|---|
Photodetector | 5 |
False Negative Result | 4 |
Incorrect Or Inadequate Test Results | 1 |
| Total Device Problems | 10 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Cypress Medical Products LLC | III | Mar-30-2019 |
| 2 | Roche Diagnostics Corporation | II | Oct-31-2018 |