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FDA 510(k)

TDX METHOTREXATE

K-Number: K830398 · 1983-03-10

ApplicantAbbott Laboratories
Decision Date1983-03-10
Product CodeLAO
DecisionSubstantially Equivalent

Device Summary

TDX METHOTREXATE is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1983-03-10 under 510(k) number K830398. The device is classified under product code LAO. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TDX METHOTREXATE?

TDX METHOTREXATE is a medical device that received FDA 510(k) clearance on 1983-03-10. The listed applicant is Abbott Laboratories. The 510(k) number is K830398.

When did TDX METHOTREXATE receive FDA 510(k) clearance?

TDX METHOTREXATE received FDA 510(k) clearance on 1983-03-10, under 510(k) number K830398.

Who is the listed applicant for TDX METHOTREXATE?

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 METHOTREXATE?

The FDA product code for TDX METHOTREXATE 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.K932615TDX(R)/TDX(R)FLX(R)MEHTOTREXATE IIAbbott LaboratoriesK884744ACA DU PONT METHOTREXATE (MTHO) METHODE.I. Dupont DE Nemours & Co., Inc.

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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