Device Classification Name |
ldl & vldl precipitation, cholesterol via esterase-oxidase, hdl
|
510(k) Number |
K100010 |
Device Name |
HDL CHOLESTEROL (HDLX) ASSAY |
Applicant |
BECKMAN COULTER, INC. |
250 S. KRAEMER BOULEVARD |
MAIL STOP E2 SE08 |
BREA,
CA
92821
|
|
Applicant Contact |
Yvette Lloyd |
Correspondent |
BECKMAN COULTER, INC. |
250 S. KRAEMER BOULEVARD |
MAIL STOP E2 SE08 |
BREA,
CA
92821
|
|
Correspondent Contact |
Yvette Lloyd |
Regulation Number | 862.1475
|
Classification Product Code |
|
Date Received | 01/04/2010 |
Decision Date | 05/14/2010 |
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
|
|
|