Device Classification Name |
Mixture, Hematology Quality Control
|
510(k) Number |
K120742 |
Device Name |
XN CHECK |
Applicant |
Streck |
7002 SOUTH 109TH ST. |
OMAHA,
NE
68128
|
|
Applicant Contact |
DEBORAH S KIPP |
Correspondent |
Streck |
7002 SOUTH 109TH ST. |
OMAHA,
NE
68128
|
|
Correspondent Contact |
DEBORAH S KIPP |
Regulation Number | 864.8625
|
Classification Product Code |
|
Date Received | 03/12/2012 |
Decision Date | 10/19/2012 |
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
|
|
|