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FDA 510(k)

QMS LAMOTRIGINE ASSAY (REAGENTS), CALIBRATORS & CONTROLS

K-Number: K062966 · 2007-01-12

ApplicantSeradyn, Inc.
Decision Date2007-01-12
Product CodeORH
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

QMS LAMOTRIGINE ASSAY (REAGENTS), CALIBRATORS & CONTROLS is the device name listed in this FDA 510(k) record. The listed applicant is Seradyn, Inc.. It received FDA 510(k) clearance on 2007-01-12 under 510(k) number K062966. 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 QMS LAMOTRIGINE ASSAY (REAGENTS), CALIBRATORS & CONTROLS?

QMS LAMOTRIGINE ASSAY (REAGENTS), CALIBRATORS & CONTROLS is a medical device that received FDA 510(k) clearance on 2007-01-12. The listed applicant is Seradyn, Inc.. The 510(k) number is K062966.

When did QMS LAMOTRIGINE ASSAY (REAGENTS), CALIBRATORS & CONTROLS receive FDA 510(k) clearance?

QMS LAMOTRIGINE ASSAY (REAGENTS), CALIBRATORS & CONTROLS received FDA 510(k) clearance on 2007-01-12, under 510(k) number K062966.

Who is the listed applicant for QMS LAMOTRIGINE ASSAY (REAGENTS), CALIBRATORS & CONTROLS?

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

What is the FDA product code for QMS LAMOTRIGINE ASSAY (REAGENTS), CALIBRATORS & CONTROLS?

The FDA product code for QMS LAMOTRIGINE ASSAY (REAGENTS), CALIBRATORS & CONTROLS is ORH.

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Other records listing Seradyn, 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.

K070645SERADYN QMS TOPIRAMATEK062204ARCHITECT CORTISOL ASSAYK060998QMS TOBRAMYCINK060709MULTIGENT GENTAMICINK052826QMS QUINIDINE. QMS QUINIDINE CALIBRATORSK051211QMS ZONISAMIDE REAGENTS, CALIBRATORS AND CONTROLS

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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.

K101305ARK LAMOTRIGINE ASSAY, CALIBRATOR & CONTROLArk 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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