TEAR VOLUME TESTS
FDA 510(k) clearance K881515 · decided 1988-05-23
Clearance details
- K-number
- K881515
- Device name
- TEAR VOLUME TESTS
- Applicant
- Visionex, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1988-04-11
- Decision date
- 1988-05-23
- Days to decision
- 42 days
- Clearance type
- Traditional
- Product code
- KYD
- Device class
- 1
- Regulation number
- 886.1800
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Sunnyvale, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| TEARTEC RAPID LACRIMAL ASSESMENT SYSTEM (K911734) | Northland Cataract & Eye Care Clinic | 1991-11-07 |
| SNO STRIPS STERILE TEARFLOW TEST STRIP (K832181) | Smith & Nephew, Inc. | 1983-08-12 |
Recalls involving this device
No recalls on record reference this clearance.