Home / 510(k) Clearances / K203833

510(k) K203833

Tacrolimus Assay Kit by Shanghai Genext Medical Technology Co., Ltd. — Product Code MLM

K203833 is an FDA 510(k) premarket notification submitted by Shanghai Genext Medical Technology Co., Ltd. for the device "Tacrolimus Assay Kit". The FDA issued a decision of Substantially Equivalent on January 27, 2023. The device falls under product code MLM (Enzyme Immunoassay, Tracrolimus), a Class II device regulated under 21 CFR 862.1678.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 27, 2023
Date Received
December 30, 2020
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

Other clearances for product code MLM

  • K173857 — Elecsys Tacrolimus (November 6, 2018)
  • 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)

FDA data resources