TEARLAB OSMOLARITY SYSTEM— 510(k) K083184
Substantially EquivalentOcusense, Inc.
FDA 510(k) clearance K083184 for TEARLAB OSMOLARITY SYSTEM, Substantially Equivalent on 2009-05-14. Applicant: Ocusense, Inc.. Device class: 1.
Clearance details
- Applicant
- Ocusense, Inc.
- Product code
- Code OND
- Device class
- Class 1
- Regulation
- 21 CFR 862.1540
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Philedelphia, PA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.