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510(k) K083487

EMIT 2000 SIROLIMUS ASSAY, EMIT 2000 SIRO/TACRO SAMPLE PRETREATMENT REAGENT, AND EMIT 200 SIROLIMUS CALIBRATOR by Siemens Healthcare Diagnostics — Product Code NRP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 30, 2009
Date Received
November 25, 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

  • K081857 — DIMENSION SIRO FLEX REAGENT CARTRIDGE AND DIMENSION SIROLIMUS CALBIRATOR, MODELS (October 30, 2008)
  • K070822 — ARCHITECT SIROLIMUS ASSAY (September 28, 2007)
  • K042411 — ABBOTT IMX SIROLIMUS MICROPARTICLE ENZYME IMMUNOASSAY (April 7, 2005)
  • DEN040008 — CEDIA SIROLIMUS ASSAY (July 28, 2004)