| Device Classification Name |
Station, Pipetting And Diluting, For Clinical Use
|
| 510(k) Number |
K894069 |
| Device Name |
ABBOTT COMMANDER FLEXIBLE PIPETTING CENTER |
| Applicant |
| Abbott Laboratories |
| One Abbott Park Rd. |
|
Abbott Park,
IL
60064
|
|
| Applicant Contact |
MATT KLAMRZYNSKI |
| Correspondent |
| Abbott Laboratories |
| One Abbott Park Rd. |
|
Abbott Park,
IL
60064
|
|
| Correspondent Contact |
MATT KLAMRZYNSKI |
| Regulation Number | 862.2750 |
| Classification Product Code |
|
| Date Received | 06/08/1989 |
| Decision Date | 08/21/1989 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Clinical Chemistry
|
| 510k Review Panel |
Clinical Chemistry
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
| Recalls |
CDRH Recalls
|
|
|