Device Classification Name |
calibrator for hemoglobin and hematocrit measurement
|
510(k) Number |
K902892 |
Device Name |
CELL-DYN CALIBRATOR |
Applicant |
UNIPATH LTD. |
850 MAUDE AVE. |
MOUNTAIN VIEW,
CA
94043
|
|
Applicant Contact |
ANDREA HERRMANN |
Correspondent |
UNIPATH LTD. |
850 MAUDE AVE. |
MOUNTAIN VIEW,
CA
94043
|
|
Correspondent Contact |
ANDREA HERRMANN |
Regulation Number | 864.8165
|
Classification Product Code |
|
Date Received | 07/02/1990 |
Decision Date | 09/10/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Hematology
|
510k Review Panel |
Hematology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|