Device Classification Name |
System, Test, Human Chorionic Gonadotropin
|
510(k) Number |
K063754 |
Device Name |
DIMENSION VISTA (TM) BHCG FLEX(R) REAGENT CARTRIDGE, AND BHCG CALIBRATOR, MODEL# K6430,KC632 |
Applicant |
DADE BEHRING, INC. |
P.O. BOX 6101 BLDG 500;M.S.514 |
NEWARK,
DE
19714 -6101
|
|
Applicant Contact |
PAMELA A JURGA |
Correspondent |
DADE BEHRING, INC. |
P.O. BOX 6101 BLDG 500;M.S.514 |
NEWARK,
DE
19714 -6101
|
|
Correspondent Contact |
PAMELA A JURGA |
Regulation Number | 862.1155
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 12/19/2006 |
Decision Date | 02/23/2007 |
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
|
|
|