Osmolality Of Tears

OND · Class I — Low Risk (general controls) · Clinical Chemistry · 21 CFR 862.1540

Classification

FDA Product Code: OND
Device class: Class I — Low Risk (general controls)
Regulation: 21 CFR 862.1540
Review panel: CH
Medical specialty: Clinical Chemistry
Submission type: 4
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

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.

Market data

Cleared 510(k) submissions: 1
Registered establishments: 4

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown