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510(k) K070822

ARCHITECT SIROLIMUS ASSAY by Fujirebio Diagnostics,Inc. — Product Code NRP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 28, 2007
Date Received
March 26, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sirolimus Test System
Device Class
Class II
Regulation Number
862.3840
Review Panel
TX
Submission Type

Sirolimus test systems are intended for the quantitative measurement of sirolimus in whole blood as an aid in management of transplant patients taking this sirolimus.

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