OND

1 FDA 510(k) clearances · Product code

FDA profile

Official device name

Osmolality Of Tears

Device class

Class I (low risk)

Regulation

21 CFR 862.1540

Medical specialty

Clinical Chemistry

FDA 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.

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