Device Classification Name |
Device, Blood Mixing And Blood Weighing
|
510(k) Number |
K842746 |
Device Name |
HYCEL ROTOR-MIXER AND/OR MULTI |
Applicant |
R & D SYSTEMS, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
R & D SYSTEMS, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 864.9195
|
Classification Product Code |
|
Date Received | 07/13/1984 |
Decision Date | 08/17/1984 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Hematology
|
510k Review Panel |
Hematology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|