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510(k) K833634

EMIT & METHOFREXATE ASSAY by Syva Co. — Product Code LAO

K833634 is an FDA 510(k) premarket notification submitted by Syva Co. for the device "EMIT & METHOFREXATE ASSAY". The FDA issued a decision of Substantially Equivalent on December 22, 1983. The device falls under product code LAO (Enzyme Immunoassay, Methotrexate), a Class U device. Syva Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 1983
Date Received
October 17, 1983
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

Other clearances by Syva Co.

  • K011878 — EMIT (R) TOX SALICYLIC ASSAY, MODEL 7SO19UL, EMIT (R) TOX SALICYLIC ACID CALIBRA (August 13, 2001)
  • K012257 — EMIT II PLUS MONOCLONAL AMPHETAMINE/METHAMPHETAMINE ASSAY MODEL OSR9C229 (August 3, 2001)
  • K011947 — EMIT 2000 VALPROIC ACID ASSAY, MODEL OSR4G229UL (July 2, 2001)
  • K011528 — EMIT 2000 PHENOBARBITAL ASSAY, MODEL OSR4D229 (June 6, 2001)
  • K011347 — EMIT 2000 PHENYTOIN ASSAY, MODEL 0SR4A229 (May 17, 2001)
  • K993980 — SYVA EMIT II PLUS ETHYL ALCOHOL ASSAY, MODELS 9K309UL/9K409UL (February 1, 2000)
  • K993981 — SYVA EMIT II PLUS PROPOXYPHENE ASSAY, MODELS 9G029UL/9G129UL (February 1, 2000)
  • K993029 — ABBOTT AEROSET THEOPHYLLINE ASSAY AND CALIBRATORS; MODELS 1E09 AND 6E89 (January 27, 2000)
  • K993988 — SYVA EMIT II PLUS COCAINE METABOLITE ASSAY, MODEL 9H029UL (January 27, 2000)
  • K993031 — ABBOTT AEROSET PHENOBARBITAL ASSEY AND CALIBRATORS;MODELS 1E08 AND 5F54 (January 27, 2000)

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)
  • K830398 — TDX METHOTREXATE (March 10, 1983)
  • K811459 — EMIT-AND METHOTREXATE ASSAY (June 9, 1981)
  • K781381 — EMIT METHATREXATE ASSAY (October 10, 1978)

FDA data resources