Device Classification Name |
Sirolimus Test System
|
510(k) Number |
K042411 |
Device Name |
ABBOTT IMX SIROLIMUS MICROPARTICLE ENZYME IMMUNOASSAY |
Applicant |
AXIS-SHIELD LTD. |
THE TECHNOLOGY PARK |
DUNDEE, TAYSIDE, SCOTLAND,
GB
DD21XA
|
|
Applicant Contact |
SUSAN LEONARD |
Correspondent |
AXIS-SHIELD LTD. |
THE TECHNOLOGY PARK |
DUNDEE, TAYSIDE, SCOTLAND,
GB
DD21XA
|
|
Correspondent Contact |
SUSAN LEONARD |
Regulation Number | 862.3840
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 09/07/2004 |
Decision Date | 04/07/2005 |
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
|
|
|