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510(k) K781381

EMIT METHATREXATE ASSAY by Dade Behring, Inc. — Product Code LAO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 10, 1978
Date Received
August 11, 1978
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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  • K073604 — DIMENSION EXL WITH LM CLINICAL CHEMISTRY SYSTEM, DIMENSION FT4L FLEX REAGENT CAR (March 13, 2008)
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  • K073072 — DIMENSION AHDL FLEX REAGENT CARTRIDGE, MODEL: DF48B (February 21, 2008)
  • K073055 — DIMENSION ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE WITH MODEL DF270 (January 3, 2008)
  • K072965 — DIMENSION VISTA C1 IN; FLEX REAGENT CARTRIDGE, CAL, CON (December 21, 2007)

Other clearances for product code LAO

  • K233454 — ONLINE TDM Methotrexate (February 20, 2024)
  • K232017 — ARK Methotrexate II Assay (December 20, 2023)
  • K163359 — ARK Methotrexate Assay (August 18, 2017)
  • 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)