TEARLAB OSMOLARITY SYSTEM
FDA 510(k) clearance K083184 · decided 2009-05-14
Clearance details
- K-number
- K083184
- Device name
- TEARLAB OSMOLARITY SYSTEM
- Applicant
- Ocusense, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2008-10-28
- Decision date
- 2009-05-14
- Days to decision
- 198 days
- Clearance type
- Traditional
- Product code
- OND
- Device class
- 1
- Regulation number
- 862.1540
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Philedelphia, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.