| Device Classification Name |
Device, Microtiter Diluting/Dispensing
|
| 510(k) Number |
K862802 |
| Device Name |
MULTI-CHANNEL MICROPIPETTES |
| Applicant |
| Dynatech Laboratories, Inc. |
| 14340 Sullyfield Cir. |
|
Chantilly,
VA
22021
|
|
| Applicant Contact |
HEIDI E CHANDONNET |
| Correspondent |
| Dynatech Laboratories, Inc. |
| 14340 Sullyfield Cir. |
|
Chantilly,
VA
22021
|
|
| Correspondent Contact |
HEIDI E CHANDONNET |
| Regulation Number | 866.2500 |
| Classification Product Code |
|
| Date Received | 07/22/1986 |
| Decision Date | 08/01/1986 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Microbiology
|
| 510k Review Panel |
Hematology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|