| Device Classification Name |
Device, Microtiter Diluting/Dispensing
|
| 510(k) Number |
K844500 |
| Device Name |
TITERTEK MICROPLATE WASHER 120 |
| Applicant |
| Flow Laboratories, Inc. |
| 7655 Old Springhouse Rd. |
|
Mclean,
VA
22102
|
|
| Applicant Contact |
JOY F POPPE |
| Correspondent |
| Flow Laboratories, Inc. |
| 7655 Old Springhouse Rd. |
|
Mclean,
VA
22102
|
|
| Correspondent Contact |
JOY F POPPE |
| Regulation Number | 866.2500 |
| Classification Product Code |
|
| Date Received | 11/20/1984 |
| Decision Date | 01/22/1985 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Microbiology
|
| 510k Review Panel |
Microbiology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|