| 510(k) Number |
K852787 |
| Device Name |
TECHNICON H*1 SYSTEM |
| Applicant |
| Technicon Instruments Corp. |
| 511 Benedict Ave. |
|
New York,
NY
10591
|
|
| Applicant Contact |
LEONARD A DWARICA |
| Correspondent |
| Technicon Instruments Corp. |
| 511 Benedict Ave. |
|
New York,
NY
10591
|
|
| Correspondent Contact |
LEONARD A DWARICA |
| Date Received | 07/01/1985 |
| Decision Date | 07/23/1985 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
Hematology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|