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Osmolality Of Tears

FDA product code OND · 1 cleared devices

Class 1 Clinical Chemistry
Regulation
21 CFR 862.1540
Review panel
CH
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2009-05-14 – 2009-05-14

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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