| Device Classification Name |
Processor, Tissue, Automated
|
| 510(k) Number |
K831313 |
| Device Name |
TISSUE-TEK V.I.P. 100/200 |
| Applicant |
| Miles Laboratories, Inc. |
| 803 N. Front St. Suite 3 |
|
Mchenry,
IL
60050
|
|
| Correspondent |
| Miles Laboratories, Inc. |
| 803 N. Front St. Suite 3 |
|
Mchenry,
IL
60050
|
|
| Regulation Number | 864.3875 |
| Classification Product Code |
|
| Date Received | 04/22/1983 |
| Decision Date | 07/28/1983 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Pathology
|
| 510k Review Panel |
Pathology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|