TEARTEC RAPID LACRIMAL ASSESMENT SYSTEM
FDA 510(k) clearance K911734 · decided 1991-11-07
Clearance details
- K-number
- K911734
- Device name
- TEARTEC RAPID LACRIMAL ASSESMENT SYSTEM
- Applicant
- Northland Cataract & Eye Care Clinic
- Decision
- Substantially Equivalent
- Date received
- 1991-04-17
- Decision date
- 1991-11-07
- Days to decision
- 204 days
- Clearance type
- Traditional
- Product code
- KYD
- Device class
- 1
- Regulation number
- 886.1800
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Kansas City, MO, 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 |
|---|---|---|
| TEAR VOLUME TESTS (K881515) | Visionex, Inc. | 1988-05-23 |
| SNO STRIPS STERILE TEARFLOW TEST STRIP (K832181) | Smith & Nephew, Inc. | 1983-08-12 |
Recalls involving this device
No recalls on record reference this clearance.