| 510(k) Number |
K850231 |
| Device Name |
ALPHA MEM MEDIUM W/O NUCLEOSIDES |
| Applicant |
| Hazleton Research Products, Inc. |
| Box 7200 |
|
Denver,
PA
17517
|
|
| Applicant Contact |
JAMES K NOEL |
| Correspondent |
| Hazleton Research Products, Inc. |
| Box 7200 |
|
Denver,
PA
17517
|
|
| Correspondent Contact |
JAMES K NOEL |
| Date Received | 01/22/1985 |
| Decision Date | 03/05/1985 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
Pathology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|