Osmolality Of Tears
Device Code: 644
Product Code(s):
OND 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.
Device Classification Information
| Device Type ID | 644 |
| Device Name | Osmolality Of Tears |
| Physical State | Tear Collection Method And Impendance Measuring Device. |
| Technical Method | Electrical Impedance Measurement To Provide An Indirect Assessment Of Osmolality. |
| Target Area | Eye |
| Regulation Description | Osmolality 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) Exempt |
| CFR Regulation Number | 862.1540 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | OND |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
Recognized Standards
Total Product Life Cycle
| Device Type ID | 644 |
| Device | Osmolality Of Tears |
| Product Code | OND |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Osmolality Test System. |
| CFR Regulation Number | 862.1540 [🔎] |
TPLC Last Update: 2019-04-02 19:38:01