Device Classification Name |
Calibrator, Multi-Analyte Mixture
|
510(k) Number |
K031682 |
Device Name |
LIPOPROTEIN CALIBRATOR |
Applicant |
BAYER HEALTHCARE, LLC |
511 BENEDICT AVE. |
TARRYTOWN,
NY
10591
|
|
Applicant Contact |
KENNETH T EDDS |
Correspondent |
BAYER HEALTHCARE, LLC |
511 BENEDICT AVE. |
TARRYTOWN,
NY
10591
|
|
Correspondent Contact |
KENNETH T EDDS |
Regulation Number | 862.1150
|
Classification Product Code |
|
Date Received | 05/30/2003 |
Decision Date | 06/25/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|