Product code OND
- Device name
- Osmolality Of Tears
- Medical specialty
- Clinical Chemistry
- Device class
- 1
- Regulation number
- 862.1540
- Review panel
- CH
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Definition
- To measure the osmolality of human tears to aid in the diagnosis of patients with signs or symptoms of dry eye disease, in conjunction with other methods of clinical evaluation.
- Source
- FDA openFDA device classification dataset