| 510(k) Number |
K841441 |
| Device Name |
SERA-250 |
| Applicant |
| Horiba Instruments, Inc. |
| 4221 Richmond Rd., NW |
|
Walker,
MI
49534
|
|
| Correspondent |
| Horiba Instruments, Inc. |
| 4221 Richmond Rd., NW |
|
Walker,
MI
49534
|
|
| Date Received | 04/06/1984 |
| Decision Date | 04/06/1984 |
| Decision |
SE - Postmarket Surveillance Required
(SESP) |
| 510k Review Panel |
Clinical Chemistry
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|