| Device Classification Name |
fluorometer, for clinical use
|
| 510(k) Number | K890908 |
| Device Name | STRATUS(R) II FLUOROMETRIC ANALYZER & ACCESSORIES |
| Applicant |
| BAXTER HEALTHCARE CORP. |
p.o. box 520672 |
miami,
FL
33152 |
|
| Contact | jeanne-marie varga |
| Regulation Number | 862.2560 |
| Classification Product Code |
|
| Date Received | 02/23/1989 |
| Decision Date | 03/24/1989 |
| Decision |
substantially equivalent (SE) |
| Classification Advisory Committee |
Clinical Chemistry
|
| Review Advisory Committee |
Clinical Chemistry
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Expedited Review |
|
|
|