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FDA 510(k)

ONLINE TDM Methotrexate

K-Number: K233454 · 2024-02-20

ApplicantRoche Diagnostics Operations
Decision Date2024-02-20
Product CodeLAO
DecisionSubstantially Equivalent

Device Summary

ONLINE TDM Methotrexate is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics Operations. It received FDA 510(k) clearance on 2024-02-20 under 510(k) number K233454. The device is classified under product code LAO. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ONLINE TDM Methotrexate?

ONLINE TDM Methotrexate is a medical device that received FDA 510(k) clearance on 2024-02-20. The listed applicant is Roche Diagnostics Operations. The 510(k) number is K233454.

When did ONLINE TDM Methotrexate receive FDA 510(k) clearance?

ONLINE TDM Methotrexate received FDA 510(k) clearance on 2024-02-20, under 510(k) number K233454.

Who is the listed applicant for ONLINE TDM Methotrexate?

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

What is the FDA product code for ONLINE TDM Methotrexate?

The FDA product code for ONLINE TDM Methotrexate is LAO.

Other records listing Roche Diagnostics Operations as applicant

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.

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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.

K232017ARK Methotrexate II AssayArk Diagnostics, Inc.K163359ARK Methotrexate AssayArk Diagnostics, 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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