Device Classification Name |
mixture, hematology quality control
|
510(k) Number |
K840302 |
Device Name |
PLT - 4 PLATELET |
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 | 864.8625
|
Classification Product Code |
|
Date Received | 01/24/1984 |
Decision Date | 03/12/1984 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Hematology
|
510k Review Panel |
Hematology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|