Device Classification Name |
System, Hemoglobin, Automated
|
510(k) Number |
K081719 |
Device Name |
STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEM |
Applicant |
STANBIO LABORATORY |
1261 NORTH MAIN ST. |
BOERNE,
TX
78006
|
|
Applicant Contact |
KIRK JOHNSON |
Correspondent |
STANBIO LABORATORY |
1261 NORTH MAIN ST. |
BOERNE,
TX
78006
|
|
Correspondent Contact |
KIRK JOHNSON |
Regulation Number | 864.5620
|
Classification Product Code |
|
Date Received | 06/18/2008 |
Decision Date | 07/18/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Hematology
|
510k Review Panel |
Hematology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|