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510(k) K081857

DIMENSION SIRO FLEX REAGENT CARTRIDGE AND DIMENSION SIROLIMUS CALBIRATOR, MODELS DR 306, DC 306 by Siemens Healthcare Diagnostics, Inc. — Product Code NRP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 30, 2008
Date Received
July 1, 2008
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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Other clearances for product code NRP

  • K083487 — EMIT 2000 SIROLIMUS ASSAY, EMIT 2000 SIRO/TACRO SAMPLE PRETREATMENT REAGENT, AND (March 30, 2009)
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  • DEN040008 — CEDIA SIROLIMUS ASSAY (July 28, 2004)