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510(k) K150168

Dimension Tacrolimus Flex® Reagent Cartridge (TAC), Dimension Tacrolimus Calibrator (TAC CAL) by Siemens Healthcare Diagnostics — Product Code MLM

K150168 is an FDA 510(k) premarket notification submitted by Siemens Healthcare Diagnostics for the device "Dimension Tacrolimus Flex® Reagent Cartridge (TAC), Dimension Tacrolimus Calibrator (TAC CAL)". The FDA issued a decision of Substantially Equivalent on November 4, 2015. The device falls under product code MLM (Enzyme Immunoassay, Tracrolimus), a Class II device regulated under 21 CFR 862.1678. Siemens Healthcare Diagnostics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 4, 2015
Date Received
January 26, 2015
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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  • K241165 — Atellica® IM High-Sensitivity Troponin I (TnIH) (July 25, 2024)

Other clearances for product code MLM

  • K203833 — Tacrolimus Assay Kit (January 27, 2023)
  • K173857 — Elecsys Tacrolimus (November 6, 2018)
  • 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)

FDA data resources