DIGILAB CAMBRIDGE PERIMETER
FDA 510(k) clearance K860115 · decided 1986-02-27
Clearance details
- K-number
- K860115
- Device name
- DIGILAB CAMBRIDGE PERIMETER
- Applicant
- Bio-Rad
- Decision
- Substantially Equivalent
- Date received
- 1986-01-13
- Decision date
- 1986-02-27
- Days to decision
- 45 days
- Clearance type
- Traditional
- Product code
- HOO
- Device class
- 1
- Regulation number
- 886.1605
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Beverly, MA, 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 |
|---|---|---|
| WELCH ALLYN GLAUCOMA DETECTOR (K941723) | Welch Allyn, Inc. | 1994-06-06 |
| MARCO PROJECTION PERIMETER (K930448) | Marco Ophthalmic, Inc. | 1993-06-21 |
| RICHMOND VISUAL FIELD SCREENER (K873912) | Richmond Products, Inc. | 1987-11-02 |
| HENSON - HAMBLIN CFS 2000 CENTRAL FIELD SCREEN (K864467) | Keeler Instruments, Inc. | 1986-12-15 |
| AUTOMATIC TANGENT SCREEN 50 (K832800) | CooperVision, Inc. | 1983-09-29 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| BIO-RAD CYCLOSPORINE BY HPLC TEST (P880032/S002) | Bio-Rad | 1996-03-01 |
| BIO-RAD CYCLOSPORINE BY HPLC TEST (P880032/S001) | Bio-Rad | 1991-03-14 |
| BIO-RAD CYCLOSPORINE BY HPLC TEST (P880032) | Bio-Rad | 1989-07-24 |