| 510(k) Number |
K875181 |
| Device Name |
MODIFIED LABELING FOR TOXI-LAB BROAD SPECTRUM |
| Applicant |
| Marion Laboratories, Inc. |
| P.O. Box 9627 |
|
Kansas City,
MI
64134
|
|
| Applicant Contact |
GUINTY, JR |
| Correspondent |
| Marion Laboratories, Inc. |
| P.O. Box 9627 |
|
Kansas City,
MI
64134
|
|
| Correspondent Contact |
GUINTY, JR |
| Date Received | 12/17/1987 |
| Decision Date | 05/27/1988 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
Toxicology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|