Device Classification Name |
mixture, control, white-cell and red-cell indices
|
510(k) Number |
K110718 |
Device Name |
CELL-CHEX WITH CPPD CRYSTALS |
Applicant |
Streck |
7002 SOUTH 109TH ST. |
OMAHA,
NE
68128
|
|
Applicant Contact |
Deborah Kipp |
Correspondent |
Streck |
7002 SOUTH 109TH ST. |
OMAHA,
NE
68128
|
|
Correspondent Contact |
Deborah Kipp |
Regulation Number | 864.8625
|
Classification Product Code |
|
Date Received | 03/15/2011 |
Decision Date | 05/26/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Hematology
|
510k Review Panel |
Hematology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|