| Device Classification Name |
Hematoxylin Weigert'S
|
| 510(k) Number |
K833424 |
| Device Name |
VEIGERT'S IRON HEMATOXYLIN STAIN-HT10-79 |
| Applicant |
| Sigma Chemical Co. |
| 803 N. Front St. Suite 3 |
|
Mchenry,
IL
60050
|
|
| Correspondent |
| Sigma Chemical Co. |
| 803 N. Front St. Suite 3 |
|
Mchenry,
IL
60050
|
|
| Regulation Number | 864.1850 |
| Classification Product Code |
|
| Date Received | 10/03/1983 |
| Decision Date | 11/03/1983 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Hematology
|
| 510k Review Panel |
Pathology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|