Device Classification Name |
Calibrator, Multi-Analyte Mixture
|
510(k) Number |
K041870 |
Device Name |
N APOLIPOPROTEIN STANDARD SERUM |
Applicant |
DADE BEHRING, INC. |
514 GBC DR. |
NEWARK,
DE
19702
|
|
Applicant Contact |
DONNA A WOLF |
Correspondent |
DADE BEHRING, INC. |
514 GBC DR. |
NEWARK,
DE
19702
|
|
Correspondent Contact |
DONNA A WOLF |
Regulation Number | 862.1150
|
Classification Product Code |
|
Date Received | 07/09/2004 |
Decision Date | 07/27/2004 |
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
|
|
|