| Device Classification Name |
Stereoscope, Ac-Powered
|
| 510(k) Number |
K830625 |
| Device Name |
CYTO-STAIN |
| Applicant |
| Richard-Allan Medical Ind., Inc. |
| 803 N. Front St. Suite 3 |
|
Mchenry,
IL
60050
|
|
| Correspondent |
| Richard-Allan Medical Ind., Inc. |
| 803 N. Front St. Suite 3 |
|
Mchenry,
IL
60050
|
|
| Regulation Number | 886.1870 |
| Classification Product Code |
|
| Date Received | 03/01/1983 |
| Decision Date | 03/24/1983 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Ophthalmic
|
| 510k Review Panel |
Pathology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|