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FDA 510(k)

ARK METHOTREXATE ASSAY, ARK METHOTREXATE CALIBRATOR, ARK METHOTREXATE CONTROL, ARK METHOTREXATE CONTROL (CALIBRATION RAN

K-Number: K111904 · 2011-10-18

ApplicantArk Diagnostics, Inc.
Decision Date2011-10-18
Product CodeLAO
DecisionSubstantially Equivalent

Device Summary

ARK METHOTREXATE ASSAY, ARK METHOTREXATE CALIBRATOR, ARK METHOTREXATE CONTROL, ARK METHOTREXATE CONTROL (CALIBRATION RAN is the device name listed in this FDA 510(k) record. The listed applicant is Ark Diagnostics, Inc.. It received FDA 510(k) clearance on 2011-10-18 under 510(k) number K111904. The device is classified under product code LAO. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARK METHOTREXATE ASSAY, ARK METHOTREXATE CALIBRATOR, ARK METHOTREXATE CONTROL, ARK METHOTREXATE CONTROL (CALIBRATION RAN?

ARK METHOTREXATE ASSAY, ARK METHOTREXATE CALIBRATOR, ARK METHOTREXATE CONTROL, ARK METHOTREXATE CONTROL (CALIBRATION RAN is a medical device that received FDA 510(k) clearance on 2011-10-18. The listed applicant is Ark Diagnostics, Inc.. The 510(k) number is K111904.

When did ARK METHOTREXATE ASSAY, ARK METHOTREXATE CALIBRATOR, ARK METHOTREXATE CONTROL, ARK METHOTREXATE CONTROL (CALIBRATION RAN receive FDA 510(k) clearance?

ARK METHOTREXATE ASSAY, ARK METHOTREXATE CALIBRATOR, ARK METHOTREXATE CONTROL, ARK METHOTREXATE CONTROL (CALIBRATION RAN received FDA 510(k) clearance on 2011-10-18, under 510(k) number K111904.

Who is the listed applicant for ARK METHOTREXATE ASSAY, ARK METHOTREXATE CALIBRATOR, ARK METHOTREXATE CONTROL, ARK METHOTREXATE CONTROL (CALIBRATION RAN?

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

What is the FDA product code for ARK METHOTREXATE ASSAY, ARK METHOTREXATE CALIBRATOR, ARK METHOTREXATE CONTROL, ARK METHOTREXATE CONTROL (CALIBRATION RAN?

The FDA product code for ARK METHOTREXATE ASSAY, ARK METHOTREXATE CALIBRATOR, ARK METHOTREXATE CONTROL, ARK METHOTREXATE CONTROL (CALIBRATION RAN is LAO.

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Other records listing Ark Diagnostics, Inc. 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.

K232522ARK Levetiracetam II AssayK232017ARK Methotrexate II AssayK231752ARK Hydrocodone AssayK201089ARK Lacosamide AssayK200197ARK Fentanyl II AssayK182280ARK Tramadol Assay

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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.K932615TDX(R)/TDX(R)FLX(R)MEHTOTREXATE IIAbbott LaboratoriesK884744ACA 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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