| Device Type ID | 604 |
| Device Name | Kit, Test, Pregnancy, Hcg, Over The Counter |
| Regulation Description | Human Chorionic Gonadotropin (HCG) Test System. |
| Regulation Medical Specialty | Clinical Chemistry |
| Review Panel | Clinical Chemistry |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(k) |
| CFR Regulation Number | 862.1155 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | LCX |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 604 |
| Device | Kit, Test, Pregnancy, Hcg, Over The Counter |
| Product Code | LCX |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Human Chorionic Gonadotropin (HCG) Test System. |
| CFR Regulation Number | 862.1155 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
CORETESTS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
GUANGZHOU WONDFO BIOTECH CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
SUGENTECH, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
False Negative Result | 5 |
| Total Device Problems | 5 |