Device Classification Name |
System, Test, Human Chorionic Gonadotropin
|
510(k) Number |
K060548 |
Device Name |
STRATUS CS ACUTE CARE BETAHCG AND NT-PROBNP TESTPAK AND TESTPAK ASSAY, CALPAK AND DILPAK |
Applicant |
DADE BEHRING, INC. |
GLASGOW BUSINESS COMMUNITY |
BLDG 500, MS 514 P.O.BOX 6101 |
NEWARK,
DE
19714 -6101
|
|
Applicant Contact |
PAMELA A JURGA |
Correspondent |
DADE BEHRING, INC. |
GLASGOW BUSINESS COMMUNITY |
BLDG 500, MS 514 P.O.BOX 6101 |
NEWARK,
DE
19714 -6101
|
|
Correspondent Contact |
PAMELA A JURGA |
Regulation Number | 862.1155
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 03/01/2006 |
Decision Date | 04/06/2006 |
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
|
Recalls |
CDRH Recalls
|
|
|