Device Classification Name |
Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)
|
510(k) Number |
K042731 |
Device Name |
ARCHITECT CA 125 II ASSAY |
Applicant |
FUJIREBIO DIAGNOSTICS, INC. |
201 GREAT VALLEY PKWY. |
MALVERN,
PA
19355 -1307
|
|
Applicant Contact |
KIMBERLY PETERSON |
Correspondent |
FUJIREBIO DIAGNOSTICS, INC. |
201 GREAT VALLEY PKWY. |
MALVERN,
PA
19355 -1307
|
|
Correspondent Contact |
KIMBERLY PETERSON |
Regulation Number | 866.6010
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 10/01/2004 |
Decision Date | 11/19/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Immunology
|
510k Review Panel |
Immunology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|