Device Classification Name |
cyclosporine |
|||
---|---|---|---|---|
510(k) Number | K080751 | |||
Device Name | ARCHITECT CYCLOSPORINE | |||
Applicant |
|
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Applicant Contact | stacey moll | |||
Correspondent |
|
|||
Correspodent Contact | stacey moll | |||
Regulation Number | 862.1235 | |||
Classification Product Code |
|
|||
Subsequent Product Code |
|
|||
Date Received | 03/18/2008 | |||
Decision Date | 09/11/2008 | |||
Decision |
substantially equivalent (SESE) |
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Regulation Medical Specialty |
Clinical Chemistry |
|||
510k Review Panel |
Toxicology |
|||
summary |
summary |
|||
FDA Review | Decision Summary | |||
Type | Traditional | |||
Reviewed by Third Party | No | |||
Combination Product |
No |
|||
Recalls | CDRH Recalls |