Device Classification Name |
Calibrator For Red-Cell And White-Cell Counting
|
510(k) Number |
K897060 |
Device Name |
CBC-CAL(TM) PLUS HEMATOLOGY CALIBRATOR/MULTIPLE |
Applicant |
R & D SYSTEMS, INC. |
614 MCKINLEY PL., N.E. |
MINNEAPOLIS,
MN
55413
|
|
Applicant Contact |
KAREN VISKOCHIL |
Correspondent |
R & D SYSTEMS, INC. |
614 MCKINLEY PL., N.E. |
MINNEAPOLIS,
MN
55413
|
|
Correspondent Contact |
KAREN VISKOCHIL |
Regulation Number | 864.8185
|
Classification Product Code |
|
Date Received | 12/18/1989 |
Decision Date | 01/02/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Hematology
|
510k Review Panel |
Hematology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|