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FDA 510(k)

EMIT METHATREXATE ASSAY

K-Number: K781381 · 1978-10-10

ApplicantDade Behring, Inc.
Decision Date1978-10-10
Product CodeLAO
DecisionSubstantially Equivalent

Device Summary

EMIT METHATREXATE ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Dade Behring, Inc.. It received FDA 510(k) clearance on 1978-10-10 under 510(k) number K781381. The device is classified under product code LAO. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EMIT METHATREXATE ASSAY?

EMIT METHATREXATE ASSAY is a medical device that received FDA 510(k) clearance on 1978-10-10. The listed applicant is Dade Behring, Inc.. The 510(k) number is K781381.

When did EMIT METHATREXATE ASSAY receive FDA 510(k) clearance?

EMIT METHATREXATE ASSAY received FDA 510(k) clearance on 1978-10-10, under 510(k) number K781381.

Who is the listed applicant for EMIT METHATREXATE ASSAY?

The FDA 510(k) record lists Dade Behring, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EMIT METHATREXATE ASSAY?

The FDA product code for EMIT METHATREXATE ASSAY 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

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

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