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FDA 510(k)

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

K-Number: K932615 · 1993-07-14

ApplicantAbbott Laboratories
Decision Date1993-07-14
Product CodeLAO
DecisionSubstantially Equivalent

Device Summary

TDX(R)/TDX(R)FLX(R)MEHTOTREXATE II is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1993-07-14 under 510(k) number K932615. The device is classified under product code LAO. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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

TDX(R)/TDX(R)FLX(R)MEHTOTREXATE II is a medical device that received FDA 510(k) clearance on 1993-07-14. The listed applicant is Abbott Laboratories. The 510(k) number is K932615.

When did TDX(R)/TDX(R)FLX(R)MEHTOTREXATE II receive FDA 510(k) clearance?

TDX(R)/TDX(R)FLX(R)MEHTOTREXATE II received FDA 510(k) clearance on 1993-07-14, under 510(k) number K932615.

Who is the listed applicant for TDX(R)/TDX(R)FLX(R)MEHTOTREXATE II?

The FDA 510(k) record lists Abbott Laboratories as the applicant. This does not by itself establish the device manufacturer.

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

The FDA product code for TDX(R)/TDX(R)FLX(R)MEHTOTREXATE II is LAO.

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Related Devices (Code: LAO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K233454ONLINE TDM MethotrexateRoche Diagnostics OperationsK232017ARK Methotrexate II AssayArk Diagnostics, Inc.K163359ARK Methotrexate AssayArk Diagnostics, Inc.K111904ARK METHOTREXATE ASSAY, ARK METHOTREXATE CALIBRATOR, ARK METHOTREXATE CONTROL, ARK METHOTREXATE CONTROL (CALIBRATION RANArk Diagnostics, Inc.K884744ACA DU PONT METHOTREXATE (MTHO) METHODE.I. Dupont DE Nemours & Co., Inc.K833634EMIT & METHOFREXATE ASSAYSyva Co.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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