| 510(k) Number |
K852107 |
| Device Name |
SICKLE-CHEX |
| Applicant |
| Streck Laboratories, Inc. |
| P.O. Box 37625 |
|
Omaha,
NE
68137
|
|
| Applicant Contact |
HAL SORNSON |
| Correspondent |
| Streck Laboratories, Inc. |
| P.O. Box 37625 |
|
Omaha,
NE
68137
|
|
| Correspondent Contact |
HAL SORNSON |
| Date Received | 05/15/1985 |
| Decision Date | 07/05/1985 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
Hematology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|