Device Classification Name |
calibrator, multi-analyte mixture
|
510(k) Number |
K072435 |
Device Name |
DIMENSION VISTA PROTEIN 3 CALIBRATOR, 3 CONTROL,1 CONTROL L, 1 CONTROL M, 1 CONTROL H |
Applicant |
DADE BEHRING, INC. |
P.O. BOX 6101 |
NEWARK,
DE
19714
|
|
Applicant Contact |
KATHLEEN ENNIS |
Correspondent |
DADE BEHRING, INC. |
P.O. BOX 6101 |
NEWARK,
DE
19714
|
|
Correspondent Contact |
KATHLEEN ENNIS |
Regulation Number | 862.1150
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 08/30/2007 |
Decision Date | 10/17/2007 |
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
|
|
|