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510(k) K173857

Elecsys Tacrolimus by Roche Diagnostics — Product Code MLM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 6, 2018
Date Received
December 20, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Tracrolimus
Device Class
Class II
Regulation Number
862.1678
Review Panel
TX
Submission Type

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Other clearances for product code MLM

  • K203833 — Tacrolimus Assay Kit (January 27, 2023)
  • K150168 — Dimension Tacrolimus Flex® Reagent Cartridge (TAC), Dimension Tacrolimus Calibra (November 4, 2015)
  • K123343 — THERMO SCIENTIFIC QMS TACROLIMUS ASSAY AND CALIBRATORS (July 11, 2013)
  • K070820 — ARCHITECT TACROLIMUS: MODEL 1L77 (August 1, 2007)
  • K063868 — MASSTRAK IMMUNOSUPPRESSANTS KIT (May 25, 2007)
  • K060502 — DIMENSION TACR FLEX REAGENT CARTRIDGE, MODEL DF107 (May 18, 2006)
  • K060385 — EMIT 2000 TACROLIMUS ASSAY AND SAMPLE PRETREATMENT REAGENT (April 6, 2006)
  • K050206 — CEDIA TACROLIMUS ASSAY (March 15, 2005)