Device Classification Name |
Calibrator, Multi-Analyte Mixture
|
510(k) Number |
K062034 |
Device Name |
DIMENSION VISTA SYSTEM DRUG 1 CALIBRATOR (DRUG 1 CAL - KC410) |
Applicant |
DADE BEHRING, INC. |
P.O. BOX 6101 |
NEWARK,
DE
19714
|
|
Applicant Contact |
VICTOR M CARRIO |
Correspondent |
DADE BEHRING, INC. |
P.O. BOX 6101 |
NEWARK,
DE
19714
|
|
Correspondent Contact |
VICTOR M CARRIO |
Regulation Number | 862.1150
|
Classification Product Code |
|
Date Received | 07/19/2006 |
Decision Date | 09/06/2006 |
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
|
|
|