510(k) K083184
- Device
- TEARLAB OSMOLARITY SYSTEM
- Applicant
- OCUSENSE, INC.
- 510(k) number
- K083184
- Product code
- OND
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2009-05-14
- Date received
- 2008-10-28
- Regulation
- 862.1540
- Classification name
- Osmolality Of Tears
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JANICE M HOGAN
- Address
- 1835 Market St., 29th Floor Philedelphia PA US 19103 19103
FDA Registration Numbers#
- 2133772
- 3017983854
- 3007137761
- 1220649
Source Documents#
Legacy Summary#
summary
FDA Review#
Decision Summary