Cleared Traditional

K830398 - TDX METHOTREXATE (FDA 510(k) Clearance)

K830398 · Abbott Laboratories · Chemistry device

Mar 1983

Decision

31d

Days

—

Risk

K830398 is an FDA 510(k) clearance for the TDX METHOTREXATE. This device is classified as a Enzyme Immunoassay, Methotrexate.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on March 10, 1983, 31 days after receiving the submission on February 7, 1983.

This device falls under the Chemistry FDA review panel.

Submission Details

510(k) Number	K830398 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	February 07, 1983
Decision Date	March 10, 1983
Days to Decision	31 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	—

Device Classification

Product Code	LAO — Enzyme Immunoassay, Methotrexate
Device Class	—