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FDA 510(k)

ARK LAMOTRIGINE ASSAY, CALIBRATOR & CONTROL

K-Number: K101305 · 2010-10-29

ApplicantArk Diagnostics, Inc.
Decision Date2010-10-29
Product CodeORH
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ARK LAMOTRIGINE ASSAY, CALIBRATOR & CONTROL 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 2010-10-29 under 510(k) number K101305. The device is classified under product code ORH. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARK LAMOTRIGINE ASSAY, CALIBRATOR & CONTROL?

ARK LAMOTRIGINE ASSAY, CALIBRATOR & CONTROL is a medical device that received FDA 510(k) clearance on 2010-10-29. The listed applicant is Ark Diagnostics, Inc.. The 510(k) number is K101305.

When did ARK LAMOTRIGINE ASSAY, CALIBRATOR & CONTROL receive FDA 510(k) clearance?

ARK LAMOTRIGINE ASSAY, CALIBRATOR & CONTROL received FDA 510(k) clearance on 2010-10-29, under 510(k) number K101305.

Who is the listed applicant for ARK LAMOTRIGINE ASSAY, CALIBRATOR & CONTROL?

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 LAMOTRIGINE ASSAY, CALIBRATOR & CONTROL?

The FDA product code for ARK LAMOTRIGINE ASSAY, CALIBRATOR & CONTROL is ORH.

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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.

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Related Devices (Code: ORH)

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.

K062966QMS LAMOTRIGINE ASSAY (REAGENTS), CALIBRATORS & CONTROLSSeradyn, 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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