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510(k) K163359

ARK Methotrexate Assay by ARK Diagnostics, Inc. — Product Code LAO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 18, 2017
Date Received
November 30, 2016
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Methotrexate
Device Class
Class U
Regulation Number
Review Panel
TX
Submission Type

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Other clearances for product code LAO

  • K233454 — ONLINE TDM Methotrexate (February 20, 2024)
  • K232017 — ARK Methotrexate II Assay (December 20, 2023)
  • K111904 — ARK METHOTREXATE ASSAY, ARK METHOTREXATE CALIBRATOR, ARK METHOTREXATE CONTROL, A (October 18, 2011)
  • K932615 — TDX(R)/TDX(R)FLX(R)MEHTOTREXATE II (July 14, 1993)
  • K884744 — ACA DU PONT METHOTREXATE (MTHO) METHOD (January 30, 1989)
  • K833634 — EMIT & METHOFREXATE ASSAY (December 22, 1983)
  • K830398 — TDX METHOTREXATE (March 10, 1983)
  • K811459 — EMIT-AND METHOTREXATE ASSAY (June 9, 1981)
  • K781381 — EMIT METHATREXATE ASSAY (October 10, 1978)