| Device Classification Name |
Bottle, Roller, Tissue Culture
|
| 510(k) Number |
K873137 |
| Device Name |
IN VITRO 2.5X ROLLER BOTTLE |
| Applicant |
| In Vitro Scientific Products |
| 2350 Valley Meadow Dr. |
|
Oak View,
CA
93022
|
|
| Applicant Contact |
JONATHAN M SERKES |
| Correspondent |
| In Vitro Scientific Products |
| 2350 Valley Meadow Dr. |
|
Oak View,
CA
93022
|
|
| Correspondent Contact |
JONATHAN M SERKES |
| Regulation Number | 864.2240 |
| Classification Product Code |
|
| Date Received | 08/10/1987 |
| Decision Date | 08/24/1987 |
| 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
|
|
|