Device Classification Name |
mixture, control, white-cell and red-cell indices
|
510(k) Number |
K090137 |
Device Name |
STAK-CHEX PLUS RETICS |
Applicant |
Streck |
7002 SOUTH 109TH ST. |
OMAHA,
NE
68128
|
|
Applicant Contact |
KERRIE OETTER |
Correspondent |
Streck |
7002 SOUTH 109TH ST. |
OMAHA,
NE
68128
|
|
Correspondent Contact |
KERRIE OETTER |
Regulation Number | 864.8625
|
Classification Product Code |
|
Date Received | 01/21/2009 |
Decision Date | 03/18/2009 |
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
|
|
|