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510(k) K203833

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

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

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  • 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)