Cleared Traditional

K932615 - TDX(R)/TDX(R)FLX(R)MEHTOTREXATE II (FDA 510(k) Clearance)

K932615 · Abbott Laboratories · Toxicology device

Jul 1993

Decision

43d

Days

—

Risk

K932615 is an FDA 510(k) clearance for the TDX(R)/TDX(R)FLX(R)MEHTOTREXATE II. This device is classified as a Enzyme Immunoassay, Methotrexate.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on July 14, 1993, 43 days after receiving the submission on June 1, 1993.

This device falls under the Toxicology FDA review panel.

Submission Details

510(k) Number	K932615 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 01, 1993
Decision Date	July 14, 1993
Days to Decision	43 days
Submission Type	Traditional
Review Panel	Toxicology (TX)
Summary	Summary PDF

Device Classification

Product Code	LAO — Enzyme Immunoassay, Methotrexate
Device Class	—