| Device Type ID | 703 |
| Device Name | Enzyme Immunoassay, Fetal Fibronectin |
| Review Panel | Clinical Chemistry |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | PMA |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | LKV |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 703 |
| Device | Enzyme Immunoassay, Fetal Fibronectin |
| Product Code | LKV |
| FDA Device Classification | Class 3 Medical Device |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Hologic, Inc. | II | Feb-21-2018 |