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510(k) K932615

TDX(R)/TDX(R)FLX(R)MEHTOTREXATE II by Abbott Laboratories — Product Code LAO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 14, 1993
Date Received
June 1, 1993
Clearance Type
Traditional
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)
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  • K111904 — ARK METHOTREXATE ASSAY, ARK METHOTREXATE CALIBRATOR, ARK METHOTREXATE CONTROL, A (October 18, 2011)
  • 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)