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510(k) K830398

TDX METHOTREXATE by Abbott Laboratories — Product Code LAO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 10, 1983
Date Received
February 7, 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

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  • K781381 — EMIT METHATREXATE ASSAY (October 10, 1978)