Device Classification Name |
Sirolimus Test System
|
510(k) Number |
K081857 |
Device Name |
DIMENSION SIRO FLEX REAGENT CARTRIDGE AND DIMENSION SIROLIMUS CALBIRATOR, MODELS DR 306, DC 306 |
Applicant |
Siemens Healthcare Diagnostics Inc. |
PO BOX 6101 |
NEWARK,
DE
19714 -6101
|
|
Applicant Contact |
GEORGE M PLUMMER |
Correspondent |
Siemens Healthcare Diagnostics Inc. |
PO BOX 6101 |
NEWARK,
DE
19714 -6101
|
|
Correspondent Contact |
GEORGE M PLUMMER |
Regulation Number | 862.3840
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 07/01/2008 |
Decision Date | 10/30/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Toxicology
|
510k Review Panel |
Toxicology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|