Device Classification Name |
Sirolimus Test System
|
510(k) Number |
K070822 |
Device Name |
ARCHITECT SIROLIMUS ASSAY |
Applicant |
FUJIREBIO DIAGNOSTICS, INC. |
201 GREAT VALLEY PARKWAY |
MALVERN,
PA
19355 -1308
|
|
Applicant Contact |
DIANA LYN DICKSON |
Correspondent |
FUJIREBIO DIAGNOSTICS, INC. |
201 GREAT VALLEY PARKWAY |
MALVERN,
PA
19355 -1308
|
|
Correspondent Contact |
DIANA LYN DICKSON |
Regulation Number | 862.3840
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 03/26/2007 |
Decision Date | 09/28/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Toxicology
|
510k Review Panel |
Toxicology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|