Cleared Traditional

TDX(R)/TDX(R)FLX(R)MEHTOTREXATE II

K932615 · Abbott Laboratories · Toxicology
Jul 1993
Decision
43d
Days
—
Risk

About This 510(k) Submission

K932615 is an FDA 510(k) clearance for the TDX(R)/TDX(R)FLX(R)MEHTOTREXATE II, 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 review panel.

Submission Details

510(k) Number K932615 FDA.gov
FDA Decision Cleared 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 —

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