Osmolality Of Tears
The Osmolality Of Tears device (product code OND) is a Class 1 in vitro diagnostic device regulated under 21 CFR 862.1540 in the Clinical Chemistry specialty (CH), exempt from premarket notification. It is intended to measure the osmolality of human tears to aid in the diagnosis of dry eye disease in patients exhibiting signs or symptoms, used in conjunction with other clinical evaluation methods. The device is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- OND
- Device Class
- FDA class 1
- Regulation Number
- 862.1540
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 4
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K083184 | TEARLAB OSMOLARITY SYSTEM | May 14, 2009 | Substantially Equivalent | Ocusense, Inc. |
FEI Numbers
This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.