KERASCAN MODEL 2000 KERATOGRAPHIC AUTO ANALYZER
FDA 510(k) clearance K864037 · decided 1986-11-13
Clearance details
- K-number
- K864037
- Device name
- KERASCAN MODEL 2000 KERATOGRAPHIC AUTO ANALYZER
- Applicant
- Kera Corp.
- Decision
- Substantially Equivalent
- Date received
- 1986-10-16
- Decision date
- 1986-11-13
- Days to decision
- 28 days
- Clearance type
- Traditional
- Product code
- HJB
- Device class
- 1
- Regulation number
- 886.1450
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Santa Clara, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Kera Corp.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| MARCO STANDARD KERATOMETERS (K930444) | Marco Ophthalmic, Inc. | 1993-08-09 |
| BURTON KERATOMETER - MODLE 2040 (K924779) | R.H. Burton Co. | 1993-04-05 |
| LTS CORNEAL MICROSCOPE LASER TOMOGRAPHIC SCANNER (K864369) | Heidelberg Instruments | 1986-12-15 |
| ACUFEX COMPARATIVE SURGICAL KERATOMETER (K852424) | Acufex Microsurgical, Inc. | 1985-09-11 |
Recalls involving this device
No recalls on record reference this clearance.