Who is the manufacturer of TDX(R)/TDX(R)FLX(R)MEHTOTREXATE II?

Abbott Laboratories filed the 510(k) submission for TDX(R)/TDX(R)FLX(R)MEHTOTREXATE II (K932615).

What is the FDA product code for TDX(R)/TDX(R)FLX(R)MEHTOTREXATE II?

LAO. as a Class U device in the TX panel.

What is the regulatory pathway for TDX(R)/TDX(R)FLX(R)MEHTOTREXATE II?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like TDX(R)/TDX(R)FLX(R)MEHTOTREXATE II?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

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

K932615 · Abbott Laboratories · LAO · Jul 14, 1993 · TX

Device Facts

Record ID	K932615
Device Name	TDX(R)/TDX(R)FLX(R)MEHTOTREXATE II
Applicant	Abbott Laboratories
Product Code	LAO · TX
Decision Date	Jul 14, 1993
Decision	SESE
Submission Type	Traditional
Device Class	Class U

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