Device Classification Name |
ldl & vldl precipitation, cholesterol via esterase-oxidase, hdl
|
510(k) Number |
K032932 |
Device Name |
DIRECT HDL-CHOLESTEROL LIQUID COLOR; DIRECT HDL/LDL-CHOLESTEROL CALIBRATOR |
Applicant |
STANBIO LABORATORY |
1261 NORTH MAIN ST. |
BOERNE,
TX
78006
|
|
Applicant Contact |
ADAOBI OGUCHI |
Correspondent |
STANBIO LABORATORY |
1261 NORTH MAIN ST. |
BOERNE,
TX
78006
|
|
Correspondent Contact |
ADAOBI OGUCHI |
Regulation Number | 862.1475
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 09/22/2003 |
Decision Date | 03/10/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|