| Device Classification Name |
Apparatus, Electrophoresis, For Clinical Use
|
| 510(k) Number |
K924021 |
| Device Name |
POWER SUPPLY |
| Applicant |
| The Binding Site, Ltd. |
| Westside Towers, Suite 1000 |
| 11845 W. Olympic Blvd. |
|
Los Angeles,
CA
90064
|
|
| Applicant Contact |
JAY H GELLER |
| Correspondent |
| The Binding Site, Ltd. |
| Westside Towers, Suite 1000 |
| 11845 W. Olympic Blvd. |
|
Los Angeles,
CA
90064
|
|
| Correspondent Contact |
JAY H GELLER |
| Regulation Number | 862.2485 |
| Classification Product Code |
|
| Date Received | 08/11/1992 |
| Decision Date | 01/28/1993 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Clinical Chemistry
|
| 510k Review Panel |
Hematology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|